Postoperative - ESRA
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C-Section 2014

Postoperative

Systemic Analgesia

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

C-SECTION-SPECIFIC EVIDENCE

  • Rectal naproxen followed by oral naproxen compared with placebo reduced postoperative pain scores, especially on the first day after surgery, reduced the need for additional analgesics and prolonged the time to first analgesic request Angle et al 2002
  • For patients receiving IT morphine, the addition of diclofenac IM every 8 h compared to diclofenac IM only on request significantly reduced pain scores at 24 h, independent of the doses of IT morphine (0.1 mg, 0.05 mg, 0.025 mg) Cardoso et al 1998
  • Rectal diclofenac 100 mg every 12 h led to less morphine consumption compared with placebo. However, pain scores were similar between the two groups Dahl et al 2002 
  • The use of diclofenac suppository 100 mg compared to no suppository reduced the need for ropivacaine and fentanyl given via PCEA from 6 to 18 h, but not from 0 to 6 h and not from 18 to 24 h. There was no significant difference between the two group in pain scores on movement Lim et al 2001
  • The postoperative administration of paracetamol and diclofenac was not superior to diclofenac alone and to paracetamol alone in pain scores at rest and on movement. However, patients receiving the combination of paracetamol and diclofenac needed significantly less morphine given via iPCA compared with paracetamol alone, but not compared with diclofenac. The groups did not differ in time to first independent ambulation Munishankar et al 2008
  • Administration of rectal diclofenac (3x 50 mg) was superior to placebo for reducing the need for supplemental analgesia. Postoperative pain was lower in patients receiving diclofenac during the first 3 h, but not afterwards Olofsson et al 2000
  • Rectal indomethacin significantly reduced pain scores and prolonged the time to first analgesic request compared with placebo Pavy et al 1995
  • The administration of intravenous ketorolac (</=120 mg/day) compared with placebo reduced the consumption of meperidine for 24 h, but not afterwards. The pain relief was similar between the two groupsPavy et al 2001
  • Diclofenac rectally plus propacetamol IV or diclofenac rectally provided more effective analgesia compared with placebo or propacetamol IV alone Siddik et al 2001  Click here for more information
  • Diclofenac suppository 100 mg after surgery followed by 3 additional doses at 8 h intervals was superior to pethidine 1 mg/kg IM after surgery followed by three additional doses at 8 h intervals for pain relief at 10 h, 18 h and 26 h, but not at 2 h. The incidence of PONV was similar between the two groups, but patients receiving pethidine reported dizziness significantly more frequently   Soroori et al 2006
  • The combination of epidural morphine 2 mg plus diclofenac sodium 75 mg IM was superior to epidural morphine 2 mg plus saline solution IM and to epidural saline plus diclofenac 75 mg IM for pain relief. However, patients receiving epidural morphine experienced PONV and pruritus significantly more often  Sun et al 1992 
  • The administration of diclofenac 75 mg IM every 12 h for 2 doses compared to no intervention reduced the need for rescue analgesia and produced significantly lower pain scores  Surakarn and Tannirandorn 2009
  • Postoperative ketorolac 30 mg IM and postoperative pethidine 75 mg IM showed similar analgesic efficacy and time to first analgesic request, although more side-effects were noted in the pethidine group Gin et al 1993
  • There were no significant differences in postoperative pain scores and supplemental analgesic use between the intravenous paracetamol group versus oral ibuprofen group  Alhashemi et al 2006
  • The administration of oral valdecoxib 20 mg every 12 h for 72 h compared with placebo was not superior in pain relief, need for supplemental analgesics and time to first analgesic request  Carvalho et al 2006
  • Spinal morphine 0.1 mg combined with IV ketorolac was not superior to different doses of spinal morphine (0.1 mg or 0.2 mg) or IV ketorolac alone in terms of pain relief and time to first analgesic request Cohen et al 1996
  • The administration of subcutaneous pethidine 1 mg/kg followed by subcutaneous pethidine 1 mg/kg with metoclopramide 10 mg IM every 8 h for three days was superior to oral diclofenac sodium 75 mg twice daily in terms of the need for rescue analgesia. However, both groups were not different in pain scores and incidence of PONV  Marzida 2009
  • NSAIDs study details  Click here for more information

Ketamine

C-SECTION-SPECIFIC EVIDENCE

  • The administration of IV low-dose ketamine as an adjuvant to bupivacaine for spinal anaesthesia was associated with longer postoperative analgesia and a reduced need for analgesia consumption than bupivacaine alone  Menkiti et al 2012
  • IV low-dose ketamine combined with IT bupivacaine provided better pain relief and lower postoperative analgesic consumption than bupivacaine alone  Sen et al 2005
  • The administration of IV ketamine 0.2 mg/kg before the induction of anaesthesia decreased postoperative pain scores, the need for supplemental analgesia and prolonged the time to first analgesic request  Ghazi-Saidi and Hajipour 2002
  • Women receiving IM S-ketamine 0.5 mg/kg followed by a 2 µg/kg/min IV continuous infusion over 12 h had a prolonged time to first analgesic request and a reduced cumulative morphine consumption compared with placebo. However, ketamine was associated with a significantly increased incidence of drowsiness, diplopia, nystagmus, dizziness, light-headness, positive dysphoria and vomiting Suppa et al 2012
  • The addition of IV ketamine compared to placebo for postoperative analgesia showed no benefit in time to first analgesic request, incidence of breakthrough pain and supplemental analgesics Bauchat et al 2011
  • The IV use of different doses of ketamine (0.25 mg/kg, 0.5 mg/kg, 1 mg/kg) compared with placebo produced similar postoperative pain scores and need for supplemental analgesia Bilgen et al 2012
  • Intraoperative IV ketamine (0.5 mg/kg) compared with placebo had no effect on pain relief and morphine consumption between 2 and 24 h Reza et al 2010
  • The administration of IV ketamine 0.5 mg/kg before the skin incision and infused continually at 0.25 mg/kg/h until the end of surgery was not superior to placebo in postoperative pain relief and supplemental fentanyl consumption Han et al 2013
  • Ketamine study details Click here for more information

Opioids

C-SECTION-SPECIFIC EVIDENCE

  • Oral opioid vs IT opioid
  • The administration of subcutaneous pethidine 1 mg/kg followed by subcutaneous pethidine 1 mg/kg with metoclopramide 10 mg IM every 8 h for three days was superior to oral diclofenac sodium 75 mg twice daily for the need for rescue analgesia. However, both groups were not different in pain scores and incidence of PONV  Marzida 2009
  • Oral oxycodone and IT morphine were similar for postoperative pain scores, but fewer patients receiving IT morphine requested supplemental analgesia McDonnell et al 2010 Click here for more information
  • Postoperative ketorolac 30 mg IM and postoperative pethidine 75 mg IM showed similar analgesic efficacy and time to first analgesic request, although more side-effects were noted in the pethidine group Gin et al 1993
  • Diclofenac suppository 100 mg after surgery followed by another three doses at 8 h intervals was superior to pethidine 1 mg/kg IM after surgery followed by another three doses at 8 h intervals for pain relief at 10 h, 18 h and 26 h, but not at 2 h. The incidence of PONV was similar between the two groups, but patients receiving pethidine experienced dizziness significantly more frequently  Soroori et al 2006
  • Oral opioid versus IT opioid study details Click here for more information
  • Systemic opioid versus conventional NSAID study details Click here for more information
  • Systemic opioid: route of administration study details Click here for more information
  • Systemic opioid vs NSAID
  • Systemic opioid: route of administration
  • Transnasal butorphanol was superior to butorphanol IV in terms of quality and duration of analgesia  Abboud et al 1991Click here for more information
  • Pain relief was significantly greater in the group receiving oral oxycodone-paracetamol compared with the group receiving morphine via iPCA for 12 h and oral oxycodone-paracetamol after 12 h  Davis et al 2006
  • The administration of piritramide via iPCA versus oral oxycodone was similar in terms of pain scores, need for supplemental anagesics and in the incidence of PONV Dieterich et al 2012
  • Subcutaneous and IM morphine produced a similar incidence of side effects and pain scores at rest, but pain scores on movement were reduced in the subcutaneous morphine group at 12, 16 and 20 h Safavi and Honarmand 2007

Paracetamol

C-SECTION-SPECIFIC EVIDENCE

  • There were no significant differences in postoperative pain scores and supplemental analgesic use between the IV paracetamol group and the oral ibuprofen group
  • The administration of IV paracetamol at the end of surgery and every 6 h for 24 h was superior to placebo for pain scores at 6, 12 and 24 h and for consumption of rescue analgesia Omar and Issa 2011
  • The postoperative administration of paracetamol and diclofenac was not superior to diclofenac alone and to paracetamol alone in pain scores at rest and on movement. However, patients receiving the combination of paracetamol and diclofenac needed significantly less morphine given via iPCA compared with paracetamol alone, but not compared with diclofenac. The groups did not differ in time to first independent ambulation Munishankar et al 2008
  • Paracetamol study details Click here for more information

Regional Analgesia

Peripheral Neural Block

C-SECTION-SPECIFIC EVIDENCE

  • In a systematic review, abdominal nerve blocks were found to reduce pain scores and postoperative opioid requirements vs placebo/no block Bamigboye and  Hofmeyr 2009
  • An iliohypogastric-ilioinguinal peripheral nerve block using 0.5% bupivacaine 24 mL compared to saline decreased pain scores and delayed the first request for analgesia  Wolfson et al 2012
  • Ilioinguinal and iliohypogastric nerve block with 0.5% ropivacaine was superior to nerve block with saline for pain scores at rest at 6, 8, 12, and 24 h and with movement at 6 and 8 h and led to a decreased supplemental analgesia need without increasing side effects Sakalli et al 2010
  • Ilioinguinal nerve block with 0.5% bupivacaine was superior to no nerve block for pain scores at 0, 4, 8 and 24 h while consumption of supplemental analgesia was decreased Bunting and McConachie 1988
  • Ilioinguinal and iliohypogastric nerve block under ultrasound guidance compared with placebo did not improve postoperative analgesia or decrease postoperative analgesic requirements  Vallejo et al 2012 
  • Iliohypogastric and ilioinguinal blocks study details Click here for more information

TAP Block

C-SECTION-SPECIFIC EVIDENCE

  • US-guided TAP block compared with no block significantly reduced postoperative morphine consumption. There were no differences between the groups in pain scores at rest and on moving, sedation level and PONV  Tan et al 2012
  • TAP block compared with no block significantly reduced postoperative tramadol consumption, postoperative pain scores at rest and on coughing Eslamian et al 2012
  • A systematic review comparing TAP block with placebo showed inconsistent results concerning time to first analgesic request, postoperative opioid consumption and postoperative pain scores Fusco et al 2014
  • Spinal morphine 100 µg, but not TAP block, improved postoperative pain relief. The additional use of bilateral TAP block with bupivacaine 2 mg/kg combined with spinal morphine did not further improve postoperative pain relief  McMorrow et al 2011
  • TAP block study details Click here for more information

TENS

C-SECTION-SPECIFIC EVIDENCE

  • IV morphine-PCA combined with Hi-TENS significantly reduced the consumption of morphine compared with IV morphine-PCA alone. However, there were no significant differences in pain scores between the two groups Binder et al 2011 
  • TENS versus placebo-TENS was superior for pain relief at rest and on movement. There was no difference in the request for additional analgesics  Smith et al 1986
  • TENS was superior to placebo-TENS for pain relief at 8 h after delivery and associated with a reduced need for supplemental analgesia Kayman-Kose et al 2014 TENS study details Click here for more information

Wound Infiltration or Infusion

C-SECTION-SPECIFIC EVIDENCE

  • In a systematic review, wound infiltration with LA reduced opioid use compared with control Bamigboye and Hofmeyr 2009
  • Combined pre- plus post-incisional local wound infiltration with lidocaine was superior to either pre-incisional or post-incisional local wound infiltration alone in postoperative pain scores  Fouladi et al 2013
  • The addition of ketorolac to subcutaneous wound instillation of bupivacaine compared with bupivacaine resulted in lower pain scores on movement, but not at rest. However, the addition of hydromorphone to LA wound instillation did not significantly decrease postoperative pain scores at all. The use of supplemental analgesics was significantly lower in the group with additional ketorolac compared to the only bupivacaine group Carvalho et al 2013
  • Ropivacaine wound instillation via an elastometric pump was superior to sterile water in the reduction of postoperative morphine consumption. Pain scores at rest did not differ between the groups during the first 6 h. However, patients receiving ropivacaine had lower pain scores during coughing and leg raising between 3 and 6 h, but not before  Fredman et al 2000
  • Continuous wound infusion with ropivacaine for 48 h was superior to epidural morphine for postoperative pain at rest and on movement. Patients receiving epidural morphine experienced significantly more PONV, pruritus and urinary retention  O’Neill et al 2012
  • Wound infiltration with tramadol or levobupivacaine was superior to saline for the consumption of supplemental analgesia and for pain relief at 15 min, but not between 2 and 24 h   Demiraran et al 2013
  • Continuous wound infusion for 48 h with 0.5% ropivacaine and ketoprofen through a multiholed wound catheter inserted below the fascia resulted in a reduced need for supplemental morphine compared with administration above the fascia. The groups did not differ in pain scores at movement. However, patients receiving administration below the fascia reported lower pain scores at 3, 6, 12, 24 and 36 h, but not at 48 h Rackelboom et al 2010
  • Subcutaneous surgical wound infiltration with bupivacaine 5 mg/mL compared with saline at 2 mL/h for 24 h resulted in similar postoperative pain scores and need for supplemental and rescue analgesia  Carvalho et al 2010
  • IT morphine was superior to wound infiltration with ropivacaine or placebo for reducing the consumption of supplemental analgesics Kainu et al 2012  Click here for more information
  • Epidural levobupivacaine was superior to levobupivacaine administered via subfascial catheter in reducing pain scores at rest during the first 4 hours, but not afterwards. However, pain scores at walking and consumption for opioids were similar between the groups  Ranta et al 2006
  • The IV system with morphine 10 mg and ketorolac 120 mg was more effective than continuous infusion of 0.2% levobupivacaine in reducing the need for supplemental analgesic and in reducing pain scores Magnani et al 2006
  • Wound infiltration or infusion study details Click here for more information

The administration of diclofenac 100 mg rectally every 8 h and propacetamol 2 g IV every 6 h (group MDP) and diclofenac 100 mg rectally every 8 h and placebo injection (group MD) were superior to placebo injection and suppository (group M) in pain scores at rest and on coughing at 2 h, but not at 6 h. Pain scores at rest at 24 h were significantly lower in patients receiving diclofenac 100 mg rectally every 8 h and propacetamol 2 g IV every 6 h (group MDP) compared with patients receiving propacetamol 2 g IV every 6 h and placebo rectally (group MP) and patients receiving placebo (group M). The incidence of pruritus and PONV were similar between the groups (Siddik 2001, N=79, LoE 1)

  • The administration of oral oxycodone 20 mg in the recovery room followed by oxycodone 10 mg 6-hourly for 24 h compared with IT morphine 100 µg given during surgery produced similar pain scores at rest and on movement.
  • The time to first analgesic request did not differ significantly between the two groups.
  • Although the supplemental consumption of oxycodone and tramadol was similar between the groups, significantly fewer patients receiving IT morphine requested supplemental analgesia.
  • However, the incidence of pruritus was significantly higher in patients receiving IT morphine (McDonnell 2010, N=111, LoE 1)
  • Transnasal butorphanol was associated with significantly longer duration of analgesia than postoperative IV butorphanol.
  • However, there were no significant differences between doses of transnasal butorphanol (2 mg vs. 1 mg followed by repeat dose of 1 mg at 60 min vs. 0.5 mg followed by repeat dose of 0.5 mg at 60 min).
  • All intervention groups were superior to placebo in patient global assessment related to pain intensity and pain relief but different doses of transnasal butorphanol were associated with similar scores (Abboud 1991, N=186, LoE 1)
reference participants’ characteristics intervention group/ control group

 

outcomes critical appraisal/ conclusion
Al-Waili 2001

Efficacy and safety of repeated postoperative administration of intramuscular diclofenac sodium in the treatment of post-cesarean section pain: a double-blind study.

 

Archives of Medical Research, 2001. 32(2): p. 148-54.

inclusion criteria

not reported

exclusion criteria

– allergy to NSAIDs

– bronchial asthma

– bleeding disturbances

– diabetes mellitus

– pregnancy-induced hypertension or preeclampsia

– liver or kidney diseases

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group D: 31.2 ± 6.65

group P: 29.7 ± 7.17

maternal weight [kg]: mean ± SD

group D: 64.2 ± 5.75

group P: 63.4 ± 5.58

gestation [week]: mean ± SD

group D: 37.8 ± 0.65

group P: 37.6 ± 0.68

indication for surgery: group D/ group P

placenta previa: 13/ 12

previous caesarean: 14/ 16

cephalopelvic disproportion: 26/ 24

malpresentation: 7/ 8

patient flow and follow up:

total patient number included:

120

randomised in:

group D: 60

group P: 60

excluded:

0

analysed:

all patients

follow-up:

48 hours

 

prior to anaesthesia

no premedication

mode of anaesthesia

GA: using atropine, sodium thiopental, suxamethonium, pancuronium hydrochloride and neostigmine (not specified)

maintained with 50% nitrous oxide and 0.5% halothane in oxygen

surgical approach

lower segment caesarean section (not specified)

postoperative pain management

given at immediate recovery with pain experience

group D:

75 mg diclofenac sodium IM

group P:

placebo

similar doses of the same medication were administered in case of pain relapse after 12 h

(</=2 injections of tested drug were allowed per day)

supplemental analgeisa

100 mg pethidine IM

rescue analgesia (after 1 h)

pethidine IM

 

postoperative pain

response within 1 h after first dose: pain relief/ no pain relief

group D: 55/ 5

group P: 10/ 50

p<0.05

supplemental and rescue analgesia [mg] during two days

group D: 2,800

group P: 22,700

p<0.05

sedation

only significantly lower in group D at 6 and 12 h, but not at 1, 3 and 24 h

methodological shortcomings

– generation of allocation sequence not reported

– allocation concealment not reported

– selective outcome reporting

– no sample size calculation

level of evidence: 1

caveat:

The authors did not analyse the data according to the group assignment. Thus, no conclusion on postoperative pain is possible.

 

 

 

Angle 2002

A randomized controlled trial examining the effect of naproxen on analgesia during the second day after cesarean delivery.

 

Anesthesia and Analgesia, 2002. 95(3): p. 741-745.

inclusion criteria

– ASA physical status I/II

– spinal anaesthesia

exclusion criteria

– contraindication to spinal anaesthesia

– known hypersensitivity or intolerance to study drugs

– diabetes

– severe preeclampsia

– active peptic ulcer disease within the past year

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group N: 34.0 ± 4.7

group P: 32.0 ± 4.9

BMI: mean ± SD

group N: 28.8 ± 4.2

group P: 29.6 ± 5.4

parity >0 [n]:

group N: 27

group P: 24

gestational age [week]: mean ± SD

group N: 38.4 ± 1.0

group P: 38.5 ± 1.0

previous caesarean deliveries >0 [N]

group N: 24

group P: 23

additional procedures [N]

group N: 1

group P: 3

patient flow and follow up:

total patient number included:

80

randomised in:

group N: 40

group P: 40

excluded:

0

analysed:

all patients

follow-up:

72 hours

prior to anaesthesia

1000-1500 crystalloid

mode of anaesthesia

SpA: 0.75% bupivacaine in 8.25% dextrose (1.2–1.8mL), fentanyl 10–20 µg, preservative-free morphine 0.2 mg IT

surgical approach

low transverse abdominal (Pfannenstiel) incision (not specified)

postoperative pain management

group N:

naproxen as a 500 mg suppository followed by oral naproxen sodium 550 mg every 12 h for six doses

group P:

placebo suppository per rectum followed by oral lactose capsules every 12 h for six doses

 

rescue suppositories as substitute for oral application in patients with vomiting in both study arms

conventional therapy as needed:

– paracetamol 300 mg, caffeine 15 mg and codeine 30 mg, one or two tablets every 3–4 h as needed

rescue medication

morphine or meperidine IM

 

postoperative pain

incision pain on sitting

only significantly reduced in group N at 36 h, but not on other measurements

(p=0.05)

incision pain at rest

only significantly reduced in group N at 36 h, but not on other measurements

(p=0.049)

uterine cramping pain at rest

significantly reduced in group N at 36 h (p=0.0004)

gas pain

significantly reduced in group N at 36 h (p=0.026)

interval worst pain

from 25 to 36 h clinically modest reduction in group N (p=0.012)

overall pain relief

significantly lower only in group N on POD 1 (p=0.0006), but not on POD 2 (p=0.057) and POD 3 (p=0.4)

time to first analgesic request [h]: median (range)

group N: 22 (1–50)

group P: 9 (1–49)

(p=0.003)

rescue medication

significantly less in group N over time compared with group P

(p<0.01)

adverse effects/ events

no significant differences in pruritus, PONV, maternal sedation or respiratory rates, vaginal blood loss, use of additional uterotonic drugs

three neonates with jaundice in group N (p=0.02)

methodological shortcomings

– no methodological shortcomings according to the evaluation sheet

level of evidence: 1

authors’ conclusion

“Adding regular doses of naproxen to spinal morphine and conventional on request oral analgesia leads to improved analgesia on day 1 and has added benefits of a lesser degree on day 2. These benefits are most evident as reductions in VAS pain scores at 36 hours, when pain levels peak in women receiving placebo. Although the use of naproxen was associated with a statistically significant improvement in overall pain relief and a reduction in the number of women with inadequate analgesia in day 1, these differences did not persist for the naproxen group as a whole on day 2.”

Cardoso 1998

Small doses of intrathecal morphine combined with systemic diclofenac for postoperative pain control after cesarean delivery.

 

Anesthesia and Analgesia, 1998. 86(3): p. 538-541.

inclusion criteria

– ASA physical status I

exclusion criteria

not reported

demographic data:

no significant differences in age, weight and height (data not shown)

patient flow and follow up:

total patient number included:

120

randomised in:

group 1: 20

group 2: 20

group 3: 20

group 4: 20

group 5: 20

group 6: 20

excluded:

0

analysed:

all patients

follow-up:

24 hours

prior to anaesthesia

10 mL/kg of lactated Ringer’s solution

mode of anaesthesia

SpA: 0.5% hyperbaric bupivacaine 15 mg combined with varying doses of morphine

group 1:

morphine 0.1 mg plus diclofenac 75 mg IM every 8 h

group 2:

morphine 0.1 mg plus diclofenac 75 mg IM on request

group 3:

morphine 0.05 mg plus diclofenac 75 mg IM every 8 h

group 4:

morphine 0.05 mg plus diclofenac 75 mg IM on request

group 5:

morphine 0.025 mg plus diclofenac 75 mg IM every 8 h

group 6:

morphine 0.025 mg plus diclofenac 75 mg IM on request

after cord clamping

groups 1, 2 and 3 received first dose of diclofenac IM

surgical approach

not reported

postoperative pain management

see above

supplemental analgesia

initially diclofenac 75 mg IM, additionally meperidine 50 mg IM if no pain relief after 30 min

 

postoperative pain [VAS]: mean ± SD

group 1 (M 0.1 + D 8/8 h):          0.22 ± 0.40*†

group 2 (M 0.1):                         0.26 ± 0.29*

group 3 (M 0.05 + D 8/8 h):        0.35 ± 0.29†

group 4 (M 0.05):                        0.54 ± 0.40

group 5 (M 0.025 + D 8/8 h):      0.23 ± 0.30†

group 6 (M 0.025):                      0.66 ± 0.62

* p<0.05, groups 1 and 2 < groups 3 and 4 = groups 5 and 6

† p<0.05, groups 1, 3, and 5 < groups 2, 4, and 6, respectively

 

pain scores of groups 1 and 2 (0.1 mg of morphine) were lower than the pain scores of groups 3 and 4 and groups 5 and 6 (0.05 and 0.025 mg of morphine, respectively)

 

pain scores of groups  1, 3, and 5 (subarachnoid morphine plus IM diclofenac every 8 h) were significantly lower compared with the pain scores of groups 2, 4, and 6, respectively (subarachnoid morphine and additional analgesics only on request)

 

supplemental analgesics: n/N

group 1 (M 0.1 + D 8/8 h):          0/20

group 2 (M 0.1):                         9/20

group 3 (M 0.05 + D 8/8 h):        0/20

group 4 (M 0.05):                       12/20

group 5 (M 0.025 + D 8/8 h):      0/20

group 6 (M 0.025):                     15/20

(p-value not stated)

no patient required systemic opioids

adverse effects/ events

treated vomiting n/N

groups 1 and 2 (morphine 0.1 mg): 10/40

groups 3 and 4 (morphine 0.05 mg): 6/40

groups 5 and 6 (morphine 0.025 mg): 4/40

treated pruritus n/N

groups 1 and 2 (morphine 0.1 mg): 23/40*

groups 3 and 4 (morphine 0.05 mg): 13/40

groups 5 and 6 (morphine 0.025 mg): 13/40

* p<0.05, groups 1 and 2 > groups 3 and 4 = groups 5 and 6

 

significantly greater incidence of severe pruritus was observed in the groups receiving 0.1 mg of subarachnoid morphine

 

no patient experienced respiratory depression

methodological shortcomings

– generation of allocation sequence not reported

– allocation concealment not reported

– no blinding of personnel and patients

– no sample size calculation

level of evidence: 2

authors’ conclusion

“… small doses of subarachnoid morphine combined with IM diclofenac every eight hours provide excellent postoperative pain control after caesarean delivery and that there are no advantages in using doses larger than 0.025 mg of subarachnoid morphine, if such a combination is used. Further studies are warranted to evaluate the efficacy of even smaller doses of morphine.”

Cohen 1996

Ketorolac and spinal morphine for postcesarean analgesia. International

 

Journal of Obstetric Anesthesia, 1996. 5(1): p. 14-18.

 

inclusion criteria

– spinal anaesthesia

exclusion criteria

– positive or suspicious history of bleeding tendencies

– sleep apnoea

– morbid obesity

-renal disease

– peptic ulcer symptoms

– asthma

– nasal polyps

– allergy to aspirin, NSAIDs or opioids

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group SM2: 30 ± 2

group SM1: 32 ± 2

group SMK: 34 ± 1

group K: 34 ± 2

maternal height [cm]: mean ± SD

group SM2: 150 ± 15

group SM1: 158 ± 3

group SMK: 160 ± 3

group K: 160 ± 3

maternal weight [kg]: mean ± SD

group SM2: 86 ± 4

group SM1: 85 ± 7

group SMK: 80 ± 5

group K: 75 ± 4

patient flow and follow up:

total patient number included:

48

randomised in:

group SM2: 11

group SM1: 12

group SMK: 13

group K:12

excluded:

0

analysed:

all patients

follow-up:

24 hours

prior to anaesthesia

1500–2000 mL of lactated Ringer’s solution

mode of anaesthesia

SpA: 0.75% hyperbaric bupivacaine 12 mg (1.6 mL) and one of four treatments:

group SM2:

spinal morphine 0.2 mg (0.4 mL)

group SM1:

spinal morphine 0.1 mg (0.2 mL) plus 0.2 mL saline

group SMK:

spinal morphine 0.1 mg (0.2 mL) plus 0.2 mL saline,

ketorolac 60 mg IV 1 h after spinal injection and 30 mg IV every 6 h for three doses

group K:

spinal saline 0.4 mL and

ketorolac 60 mg IV 1 h after spinal injection and 30 mg IV every 6 h for three doses.

intraoperative pain management

fentanyl 50–100 µg IV

surgical approach

not reported

postoperative pain management

supplemental analgesia

meperidine 12.5–25 mg IV, <50 mg/h

 

intraoperative pain [VAS]:

no significant differences between the four groups

(p-value not reported)

postoperative pain [VAS]:

no significant differences between the four groups during the first 20 h

(p-value not reported)

time to first analgesic request [min]: mean ± SD

group SM2: 828 ± 169

group SM1: 603 ± 182

group SMK: 697 ± 143

group K: 693 ± 165

(p=NS)

supplemental analgesics:

patients given meperidine: %

group SM2: 72

group SM1: 75

group SMK: 77

group K: 67

(p=NS)

total meperidine dosage (mg): mean ± SD

group SM2: 46 ± 21

group SM1: 72 ± 22

group SMK: 39 ± 11

group K: 49 ± 15

(p=NS)

adverse effects/ events

pruritus: %

group SM2: 100

group SM1: 83

group SMK: 85

group K:17*

* p=0.0001 compared with all other groups

two patients aborted study due to severe pruritus

nausea: %

group SM2: 45

group SM1: 50

group SMK: 31

group K: 33

(p=NS)

vomiting: %

group SM2: 36

group SM1: 17

group SMK: 15

group K: 0

(p=NS)

sedation

similar between the four groups

methodological shortcomings

– generation of allocation sequence not reported

– no sample size calculation

level of evidence: 1

authors’ conclusion

“… we found no better pain relief with a combination of intravenous ketorolac and spinal morphine than with either drug given alone. Although patients receiving spinal morphine had a high incidence of pruritus, overall satisfaction was high and similar in all groups.”

Dahl 2002

High-dose diclofenac for postoperative analgesia after elective caesarean section in regional anaesthesia.

 

International Journal of Obstetric Anesthesia, 2002. 11(2): p. 91-94.

 

 

inclusion criteria

– spinal anaesthesia

– single fetus in cephalad position

exclusion criteria

– BMI >30 kg/m²

– contraindication to NSAIDs

demographic data:

no significant differences in age, weight and height

maternal age [yr.]: mean ± SD

group D: 32.2 ± 4.4

group P: 32.9 ± 4.4

ASA I (n)/ ASA II (n)

group D: 39/1

group P: 39/3

patient flow and follow up:

total patient number included:

84

randomised in:

group D: 42

group P: 42

excluded:

group D: 0

group P: extensive bleeding: 2

analysed:

group D: 42

group P: 40

follow-up:

32 hours

mode of anaesthesia

SpA: hyperbaric bupivacaine 5 mg/mL, 2.2–2.4 mL

surgical approach

not reported

after surgery

500 mL dextran-70

postoperative pain management

all women

rectal paracetamol 1000 mg every 6 h for 32 h

group D:

rectal diclofenac 100 mg after surgery, 12 h and 24 h

group P:

rectal placebo suppository given in same time intervals

rescue analgesia

if VAS >30 mm

morphine 2.5 mg IV as needed

postoperative pain [VAS]:

no significant differences between the groups

cumulative morphine consumption

significantly reduced in group D from 5 h – 32 h, but not before

(p=0.048)

adverse effects/ events

nausea (needed treatment): n

group D: 0

group P: 4

(p=NS)

methodological shortcomings

– generation of allocation sequence not reported

– no sample size calculation

level of evidence: 1

authors’ conclusion

“…diclofenac suppositories, 100 mg twice daily after caesarean section in regional anaesthesia, was opioid-sparing. The use of diclofenac 200 mg daily did not seem to have any significant side-effects in this group of healthy parturients.”

Lim 2001

Single dose diclofenac suppository reduces post-Cesarean PCEA requirements.

 

Canadian Journal of Anesthesia, 2001. 48(4): p. 383-386.

 

inclusion criteria

– ASA physical status I/II

exclusion criteria

– patients who declined regional anaesthetic

– history of allergy to NSAIDs

– bleeding tendency

– bronchial asthma

– peptic ulcer disease

– liver disease

– kidney disease

– unable to perform PCEA

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group D: 30 (22–39)

group P: 32 (26–39)

maternal height [cm]: mean ± SD

group D: 156 ± 6

group P: 155 ± 6

maternal weight [kg]: mean ± SD

group D: 66 ± 14

group P: 67 ± 11

patient flow and follow up:

total patient number included:

48

randomised in:

group D: 24

group P: 24

excluded: 9

group D: 5

– PCA malfunction: 2

– epidural catheter dislodged: 1

– data collection incomplete: 1

– request for the removal of pump: 1

group P: 4

– epidural catheter dislodged: 1

– data collection incomplete: 2

– administration of meperidine IM: 1

analysed: unclear

data from these patients were included up to the assessment time before premature exclusion from the study

follow-up:

24 hours

prior to anaesthesia

– 30 mL 0.3 molar concentration sodium citrate

– 500 mL Hartmann`s solution IV

-infiltration of 1% lidocaine

mode of anaesthesia

SpA: 0.5% hyperbaric bupivacaine 1.5 mL (7.5 mg) IT,

no additional epidural anaesthetics needed

surgical approach

lower segment caesarean section (not specified)

postoperative pain management

group D:

diclofenac suppository 100 mg

group P:

no suppository

supplemental analgesia

PCEA: bolus dose of 4 mL of 0.2% ropivacaine with fentanyl 2 µg/mL (lockout 10 min, </=12 mL/h, no basal infusion)

 

postoperative pain on movement [VAS]:

no significant differences between the groups

cumulative PCEA consumption [mL]: mean ± SD

0–6 h

group D: 13.1 ± 7.7

group P: 18.1 ± 11.9

(p=NS)

6–12 h

group D: 10.0 ± 3.1

group P: 18.7 ± 6.1

(p<0.005)

12–18 h

group D: 11.1 ± 5.2

group P: 20.0 ± 7.8

(p<0.005)

18–24 h

group D: 16.4 ± 6.3

group P: 17.7 ± 12.5

(p=NS)

adverse effects/ events

motor blockade: n

at 6 and 12 h: [modified Bromage 2]

group D: 1

group P: 1

at 24 h: [modified Bromage 0]/ [modified Bromage 1]

group D: 18/ 1

group P: 0/ unclear

none of the patients experienced:

– nausea

– vomiting

– pruritus

– excessive sedation

methodological shortcomings

– allocation concealment unclear

– method of blinding unclear

– no sample size calculation

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“A single administration of 100 mg diclofenac suppository is effective in reducing post-caesarean epidural local anaesthetic/ opioid requirements by 33% for the first 24 h postoperatively”

Marzida 2009

A randomized controlled study comparing subcutaneous pethidine with oral diclofenac for pain relief after caesarean section.

 

Journal of the University of Malaya Medical Centre, 2009. 12(2): p. 63-69.

 

inclusion criteria

– single fetus

– spinal anaesthesia

exclusion criteria

– <18 yr.

– known contraindication to NSAIDs:

– hypersensitivity

– renal impairment

– bleeding disorders

– gastric problems

– asthmatics

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group P: 30.4 ± 4.4

group D: 31.4 ± 5.6

parity [n]: mean IQR

group P: 2.0 (1.00; 2.75)

group D: 2.5 (1.25; 3.75)

patient flow and follow up:

total patient number included:

40

randomised in:

group P: 20

group D: 20

excluded:

0

analysed: 40

one patient discharged before last evaluation was included in analysis

follow-up:

72 hours

prior to anaesthesia

ranitidine 150 mg PO night  and the morning of surgery, respectively;

sodium citrate 30 mL

mode of anaesthesia

SpA: 0.5% hyperbaric bupivacaine 2–2.5 mL IT,

no additional analgesia was given

surgical approach

not reported

postoperative pain management

after surgery

0.5% plain bupivacaine 20 mL,

rectal diclofenac suppository 50 mg

group P:

subcutaneous pethidine 1 mg/kg before discharged from recovery room,

continued with subcutaneous pethidine 1 mg/kg with metoclopramide 10 mg IM every 8 h for three days

group D:

diclofenac sodium 75 mg PO twice daily, first dose given on the evening of surgery

supplemental analgesia

pethidine 1 mg/kg subcutaneously 3 hourly as needed

 

postoperative pain [VAS]:

no significant differences between the groups

need for supplemental analgesia on day 1: n

group P: 0

group D: 12

(p-value not reported)

satisfaction score

similar between groups on day 1, significantly higher in group D on day 2 and day 3

adverse effects/ events

sedation scores: median (IQR)
day 1
group P: 2 (2, 2)
group D: 0 (0, 2)

(p<0.001)

day 2
group P: 1 (1, 2)
group D: 0 (0, 0)

(p<0.001)

day 3
group P: 0 (0, 1)
group D: 0 (0, 0)

(p=0.024)

no significant differences in:

– PONV (only two women in group P)

methodological shortcomings

– allocation concealment unclear

– no blinding of patients and physicians

level of evidence: 1

authors’ conclusion

“…the use of regular oral diclofenac 75 mg twice daily may not provide comparable pain relief on the first postoperative day, but it provided superior patient satisfaction as compared to the traditional method of subcutaneous pethidine 1 mg/kg. Although offering less than perfect analgesia, oral diclofenac provided comfort to the patients with few side effects and can be monitored on the ward. The use of oral diclofenac 150 mg daily did not seem to have any significant side effects in this group of healthy parturient. Therefore, it is still acceptable to use diclofenac alone as an alternative pain relief following caesarean section, in view of the other benefits of a non-opioid analgesics and especially in places where newer techniques are neither possible nor practical. However this is only a pilot study, a bigger sample size would be needed to confirm the findings.”

Munishankar 2008

A double-blind randomised controlled trial of paracetamol, diclofenac or the combination for pain relief after caesarean section.

 

International Journal of Obstetric Anesthesia, 2008. 17(1): p. 9-14.

 

inclusion criteria

– >/=37 gestational weeks

– between 18 and 45 yr.

exclusion criteria

– any significant history of maternal medical or obstetric illness

– any evidence of fetal compromise within the current pregnancy

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group P: 31.9 ± 6.2

group D: 29.7 ± 6.4

group PD: 28.8 ± 5.8

maternal height [cm]: mean ± SD

group P: 160.5 ± 6.4

group D: 159.4 ± 6.6

group PD: 163.2 ± 6.0

maternal weight [kg]: mean ± SD

group P: 73.0 ± 13.1

group D: 73.3 ± 13.3

group PD: 76.0 ± 14.3

gestation (wk.): mean ± SD

group P: 39.0 ± 0.8

group D: 38.7 ± 0.5

group PD:39.1 ± 0.9

patient flow and follow up:

total patient number included:

78

randomised in:

group P: 26

group D: 26

group PD: 26

excluded: 4

group P:

request for rescue analgesia: 2

group D:

due to excessive vomiting: 1

group PD:

due to excessive vomiting: 1

analysed: 74

group P: 23

group D: 25

group PD: 26

follow-up:

24 hours

mode of anaesthesia

infusion of Ringers Lactate IV

SpA: bupivacaine 5 mg/mL with dextrose 80 mg/mL in 2.25–2.5 mL, mixed with fentanyl 12.5 µg (total volume 2.5–2.75 mL)

– if systolic blood pressure <100 mmHG increments of IV ephedrine 3–6 mg

surgical approach

not reported

postoperative pain management

suppositories given at the end of surgery

group P:

paracetamol 1 g

group D:

diclofenac 100 mg

group PD:

paracetamol 1 g and diclofenac 100 mg

6 h after surgery

group P:

oral paracetamol 1 g 6-hourly and placebo 8-hourly

group D:

placebo 6-hourly and oral diclofenac 50 mg 8-hourly

group PD:

oral paracetamol 1 g 6-hourly and and oral diclofenac 50 mg 8-hourly

supplemental analgesia

morphine via iPCA (bolus 1 mg, lockout 5 min.)

rescue analgesia:

morphine IV (not specified)

 

postoperative pain [VAS]:

at rest and on movement

no significant differences between the groups

morphine consumption via iPCA

in consecutive 4 h periods up to 24 h

differences were significant between all time periods except 8–11.9 h and 12–15.9 h.

consumption after 24 h: mean ± SD

group P: 54.5 ± 28.5*

group D: 44.1 ± 24.4

group PD:33.8 ± 23.8*

(p=0.02, difference between groups)

iPCA attempts: mean ± SD

group P: 68.7 ± 35.6*

group D: 63.7 ± 31.8

group PD: 40.3 ± 30.3*

(p=0.04, difference between groups))

satisfaction score

significantly higher in group D and group PD compared with group P

(p<0.001)

recovery

time to first independent mobilisation (h): mean ± SD

group P: 22.8 ± 2.8

group D: 24.6 ± 14.4

group PD:19.4 ± 6.7

(p=0.39)

adverse effects/ events

no significant differences in:

– heart rate

– systolic and diastolic blood pressure

methodological shortcomings

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“…patients given a combination of paracetamol and diclofenac for pain relief after caesarean section use significantly less morphine compared to patients given paracetamol alone. Almost one third of patients in the paracetamol group were dissatisfied with pain management after surgery. Larger studies are required to investigate the differences between diclofenac alone and the combination of paracetamol and diclofenac, particularly when long-acting intrathecal opioids are used.”

Olofsson 2000

Diclofenac in the treatment of pain after caesarean delivery: An opioid-saving strategy.

 

European Journal of Obstetrics Gynecology and Reproductive Biology, 2000. 88(2): p. 143-146.

inclusion criteria

– >/=38 gestational weeks

– uncomplicated pregnancy

– indication for operation were cephalo-pelvic disproportions, breech position or repeated sections

exclusion criteria

– not reported

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group D: 31.2 ± 1.25

group P: 32 ± 0.82

primiparous (n)/ multiparous (n)

group D: 8/ 17

group P: 14/ 11

breech (n)

group D: 8

group P: 11

repeat c-section (n)

group D: 4

group P: 3

cephalo-pelvic disproportions (n)

group D: 13

group P: 11

patient flow and follow up:

total patient number included:

50

randomised in:

group D: 25

group P: 25

excluded:

unclear

analysed:

unclear

follow-up:

24 hours

mode of anaesthesia

2.5% Ringer-Dextrane solution 1000–1500 mL preceded by 3 g Dextrane haptene

SpA: 0.5% bupivacaine 12.5 mg (2.5 mL hyperbaric solution with 8% glucose)

surgical approach

not reported

intraoperative rescue analgesia

fentanyl 0.1 mg or dixyrazin 10 mg

postoperative pain management

first suppository given at the end of surgery

group D:

3x diclofenac 50 g during first 24 h

group P:

placebo suppositories during the same period

supplemental analgesia

ketobemidone via iPCA (dose of 1 mg, lockout 6 min., </=10 mg/h),

rescue analgesia

ketobemidone 5–10 mg IV

 

intraoperative rescue analgesia fentanyl/dixyrazin [n]

group D: 2/4

group P: 2/4

(p-value not reported)

postoperative rescue analgesia [n]

group D: 8

group P: 7

(p-value not reported)

ketobemidone consumption during first 20 h

total dose [mg]: mean ± SD

group D: 30.9 ± 3.3

group P: 47.6 ± 3.08

(p<0.01)

demands from iPCA: mean ± SD

group D: 43.6 ± 5.8

group P: 72.6 ± 7.55

(p<0.004)

delivery refused: mean ± SD

group D: 12.6 ± 3.72

group P: 25 ± 5.48

(p<0.03)

postoperative pain [VAS]:

significantly reduced in group D compared with group P during the first 3 h, but not afterwards

(p=0.025)

adverse effects/ events

none of the patients had any bleeding complications

methodological shortcomings

– allocation concealment not reported

– selective outcome reporting

– incomplete outcome data

– no sample size calculation

level of evidence: 1

authors’ conclusion

“This study demonstrates that adding 150 mg diclofenac administered rectally after surgery in addition to PCA systemic opioids increases the quality of pain relief and reduces the need for opioids after Caesarean section performed under spinal anaesthesia.”

Pavy 1995

Rectal indomethacin potentiates spinal morphine analgesia after caesarean delivery.

 

Anaesthesia and Intensive Care, 1995. 23(5): p. 555-559.

 

inclusion criteria

– ASA physical status I/II

exclusion criteria

– diabetes

– history of asthma

– intolerance to NSAIDs

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group I: 32.8 ± 4.98

group P: 29.6 ± 5.2

weight [kg]: mean  ±SD

group I: 84.6 ± 17

group P: 76.6 ± 17.7

height [cm]; mean ± SD

group I: 161 ± 11

group P: 162.3 ± 7.4

primiparous [n]

group I: 4

group P: 4

patient flow and follow up:

total patient number included:

30

randomised in:

group I: 15

group P: 15

excluded:

0

analysed:

all patients included

follow-up:

72 hours

mode of anaesthesia

preloading with 1000–2000 mL of warmed crystalloid

SpA: 0.75% hyperbaric bupivacaine 1.2–1.4 mL, morphine 250–300 µg, fentanyl 10–15 µg

surgical approach

Pfannenstiel incision

(not specified)

postoperative pain management

group I:

indomethacin 100 mg suppositories (200 mg immediately, 100 mg twice-daily thereafter)

group P:

suppository: haemorrhoidal preparation containing zinc oxide, balsam and benzyl benzoate

supplemental analgesia

oral codeine 30 mg and paracetamol 325 mg, three-hourly as needed,

parenteral opioids if requested

 

time to first analgesic request [h]: median (range)

group I: 39.6 (7–82)

group P: 9 (2–76)

(p<0.003)

total additional analgesic requests [n]: median (range)

group I: 4 (0–11)

group P:11 (1–20)

(p<0.0009)

no requests for parenteral opioids

postoperative pain [VAS]:

POD 1 on movement

group I: 1.4 ± 1.2

group P: 5.1 ± 2.1

(p<0.00001)

POD 2 on movement

group I: 3.3 ± 2

group P: 5.5 ± 2.9

(p=NS)

POD 3 on movement

group I: 2.8 ±1.7

group P: 4.5 ±2.7

(p=NS)

mean pain on movement at all times [VAS]
group P higher score than group I
(p=0.0003)

incisional pain

no difference between groups on POD 1, POD 2 and POD 3

visceral pain

no difference between groups on POD 1, POD 2 and POD 3

adverse effects/ events

no differences in:

– vaginal blood loss

– uterine cramps

– itching

– nausea

no episodes of

– respiratory depression

– urinary retention

methodological shortcomings

– allocation concealment not reported

level of evidence: 1

authors’ conclusion

“Rectal indomethacin use following caesarean delivery leads to significantly improved pain relief compared with placebo. The combination of spinal morphine and rectal indomethacin leads to high-quality postoperative analgesia.”

Pavy 2001

The effect of intravenous ketorolac on opioid requirement and pain after cesarean delivery.

 

Anesthesia and Analgesia, 2001. 92(4): p. 1010-1014.

inclusion criteria

– ASA physical status I/II

exclusion criteria

– contraindications to NSAID

– opioid use

– unwillingness to use PCEA

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group K: 29.3 ± 5.1

group P: 30.8 ± 3.1

weight [kg]: mean ± SD

group K: 79.9 ± 11.9

group P: 77.4 ± 10.6

patient flow and follow up:

total patient number included:

50

randomised in:

group K: 26

group P: 24

excluded: 6

– failure to obtain data: 6

analysed:

group K: 24

group P: 20

follow-up:

72 hours

mode of anaesthesia

CSEA: 0.5% hyperbaric bupivacaine 10–12.5 mL and fentanyl 12.5 µg IT

surgical approach

not reported

postoperative pain management

group K:

product information was altered

first six cases:

after delivery: initial dose of ketorolac 30 mg

PACU: IV infusion of ketorolac 120 mg over 24 h

following cases

after delivery: initial dose of ketorolac 15 mg

PACU: IV infusion of ketorolac 105 mg over 24 h (total 120 mg)

group P:

after delivery: initial dose of saline

PACU: IV infusion of normal saline 500 mL over 24 h

supplemental analgesia

epidural meperidine via PCA (6 mg/mL, 4 mL incremental dose, 15 min lockout)

infusion stopped after 24 h and continued with meperidine and oral paracetamol 500 mg/ codeine 30 mg (1–2 capsules 6-hourly as needed)

time to first analgesic request [min]: median (IQR)

group K: 155 (78, 200)

group P: 90 (63, 125)

(p=0.06)

consumption of meperidine: median (IQR)

                        group K               group P

0–12 h           114 (60, 183)     193 (129, 249)

(p=0.013)

12–24 h         105 (57, 150)     150 (108, 226)

(p=0.012)

24–48 h         183 (69, 300)     216 (177, 357)

(p=NS)

0–72 h           546 (413, 786)   792 (672, 963)

(p=NS)

postoperative pain [VAS] on movement:

no significant differences between groups

satisfaction with analgesia

no significant differences between groups

recovery

no significant difference in time to

– first ambulation

– first ingestion of fluid

– first ingestion of solid

– first passage of flatus

– removal of urinary catheter

adverse effects/ events

free of pruritus (%):

at 24 h

group K: 58

group P: 35

(p=NS)

at 48 h

group K: 4

group P: 40

(p=0.006)

no significant difference in:

– vaginal blood loss

– nausea

– sedation

 

methodological shortcomings

– allocation concealment not reported

– incomplete outcome data

level of evidence: 1

authors’ conclusion

“…IV ketorolac used for 24 h as an adjunct to PCEA meperidine produced a dose-sparing effect of approximately 30%, but did not significantly improve pain relief, reduce opioid-related side effects or change patient outcomes.”

Siddik 2001

Diclofenac and/or propacetamol for postoperative pain management after caesarean delivery in patients receiving patient controlled analgesia morphine

 

Regional Anesthesia and Pain Medicine 2001. 26 (4):p. 310-315

inclusion criteria

– ASA physical status I/II

exclusion criteria

– bleeding disturbances

– allergy to NSAIDs

– atopia

– bronchial asthma

– diabetes mellitus

– liver or kidney diseases

– abuse of drugs or alcohol

– pregnancy-induced hypertension or preeclampsia

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group MDP: 31.5 ± 4.4

group MD: 31.4 ± 6

group MP: 31.0 ± 4.6

group M: 30.6 ± 5.1

weight [kg]: mean ± SD

group MDP: 81.3 ± 11.2

group MD: 78.4 ± 9.6

group MP: 72.9 ± 10.1

group M: 80.9 ± 13.3

parity: primiparus [%]/ multiparus [%]

group MDP: 26.3/ 73.7

group MD: 25/ 75

group MP: 26.3/ 73.7

group M: 31.6/ 68.4

gestational age [wk.]: mean ± SD

group MDP: 37.4 ± 2.7

group MD: 38.2 ± 2.1

group MP: 37.6 ± 2.2

group M: 37.4 ± 2.1

patient flow and follow up:

total patient number included:

80

randomised in:

group MDP: 20

group MD: 20

group MP: 20

group M: 20

excluded: 1

– technical problems with PCA: 1

analysed:

group MDP: 19

group MD: 20

group MP: 20

group M: 20

follow-up:

24 hours

mode of anaesthesia

polygeline 500 mL IV

SpA: 12 mg of hyperbaric bupivacaine (7.5 mg/mL) in 8.25% dextrose with fentanyl 12.5 µg

surgical approach

not reported

postoperative pain management

group M:

placebo (injection and suppository)

group MD:

diclofenac 100 mg rectally every 8 h and placebo injection

group MP:

propacetamol 2 g IV every 6 h and placebo rectally

group MDP:

diclofenac 100 mg rectally every 8 h and propacetamol 2 g IV every 6 h

supplemental analgesia

morphine PCA

bolus of 1 mg , lockout 6 min, </=25 mg/4 h for 24h

if analgesia was inadequate

additional boluses given by anaesthesiologist until VAS <3, then reduced the lockout time to 5 min and increase the maximum dose

 

 

morphine consumption [mg]: mean ± SD (range)

2 h

group MDP: 3.1 ± 4.1 (0–15)

group MD: 2.5 ± 3 (0–12)

group MP: 6.2 ± 5 (0–17)

group M: 6.3 ± 5.3 (0–17)

(p<0.05 in group MDP versus groups MP and M;

p<0.05 in group MD versus groups MP and M)

6 h

group MDP: 13.6 ± 8.4 (2–35)

group MD: 15.2 ± 7.2 (5–30)

group MP: 24 ± 9.3 (8–41)

group M: 28.7 ± 13.1 (1–52)

(p<0.05 in group MDP versus groups MP and M;

p<0.05 in group MD versus groups MP and M)

24 h

group MDP: 28.3 ± 15.8 (3–68)

group MD: 36 ± 18 (12–63)

group MP: 61.1 ± 23 (28–107)

group M: 66.7 ± 20 (33–100)

(p<0.05 in group MDP versus groups MP and M;

p<0.05 in group MD versus groups MP and M)

need for additional boluses: n

group MDP: 0

group MD: 0

group MP: 5

group M: 8

(p<0.05)

postoperative pain [VAS]: mean ± SD (range)

at rest 2 h

group MDP: 2.7 ± 2 (0–7)

group MD: 2.9 ± 2.6 (0–9)

group MP: 4.3 ± 2.5 (0–8)

group M: 6 ± 3 (0–10)

(p<0.05 in groups MDP and MD versus group M)

at rest 6 h

group MDP: 3.7 ± 1.9 (1–9)

group MD: 3.4 ± 1.8 (0–7)

group MP: 3.9 ± 2 (1–9)

group M: 3.8 ± 1.7 (0–7)

(p=NS)

at rest 24 h

group MDP: 1.5 ± 1.3 (0–5)

group MD: 2.3 ± 2 (0–7)

group MP: 3.5 ± 2 (0–8)

group M: 3.2 ± 2.7 (0–10)

(p<0.05 in group MDP versus groups MP and M)

on coughing 2 h

group MDP: 3.6 ± 3.1 (0–10)

group MD: 4 ± 3.1 (0–8)

group MP: 5.3 ± 3.2 (0–10)

group M: 6.9 ± 3.1 (0–10)

(p<0.05 in groups MDP and MD versus group M)

on coughing 6 h

group MDP: 5.5 ± 2.2 (3–10)

group MD: 5.1 ± 2.9 (0–10)

group MP: 5.6 ± 2 (3–9)

group M: 6.1 ± 1.7 (2–9)

(p=NS)

on coughing 24 h

group MDP: 3.5 ± 1.6 (1–6)

group MD: 4.8 ± 2.2 (1–9)

group MP: 5.3 ± 2 (2–9)

group M: 5.3 ± 2.2 (0–9)

(p=NS)

satisfaction

good outcome [n]/ bad outcome [n]

group MDP: 19/ 0

group MD: 20/ 0

group MP: 17/ 3

group M: 17/ 3

(p=NS)

adverse effects/ events

pruritus: n

group MDP: 6

group MD: 5

group MP: 4

group M: 8

(p=NS)

nausea and/ or vomiting: n

group MDP: 3

group MD: 2

group MP: 3

group M: 4

(p=NS)

sedation: n

group MDP: 0

group MD: 1

group MP: 1

group M: 3

(p=NS)

methodological shortcomings

– allocation concealment not reported

level of evidence: 1

authors’ conclusion

“…the concurrent administration of diclofenac in parturients receiving PCA morphine after caesarean delivery improves analgesia and has a significant morphine-sparing effect compared with propacetamol and placebo alone. We were unable to show a significant morphine-sparing effect of propacetamol or additive effect of propacetamol and diclofenac in this group of patients.”

Soroori 2006

The comparison between suppository diclofenac and pethidine in post-cesarean section pain relief: A randomized controlled clinical trial.

 

Journal of Research in Medical Sciences, 2006. 11(5): p. 292-296.

 

inclusion criteria

– gestational age >28 wk.

– no history of convulsion, drug sensitivity, opioid addiction, epigastric pain and gastrointestinal bleeding

exclusion criteria

– operation time >90 min

– any complication during surgery that needed another operation

– postoperative ileus

– any other state which required administration of other analgesics

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group D: 27.2 ± 6.5

group P: 26.4 ± 5.6

gestational age [wk.]: mean ± SD

group D: 38.8 ± 1.7

group P: 39.1 ± 1.4

parity: single parity [% (n)]/ multiparous [% (n)]

group D: 99 (82.5)/ 21 (17.5)

group P: 109 (90.8)/ 11 (9.2)

previous abortion: 0 [n (%)]/ >/=1 [n (%)]

group D: 105 (87.5)/ 15 (12.5)

group P: 104 (86.7)/ 16 (13.3)

previous c-section: yes [n (%)]/ no [n (%)]

group D: 29 (24.2)/ 91 (75.8)

group P: 25 (20.8)/ 95 (79.2)

patient flow and follow up:

total patient number included:

240

randomised in:

group D: 120

group P: 120

excluded:

0

analysed:

group D: 120

group P: 120

follow-up:

26 hours

mode of anaesthesia

SpA: hyperbaric lidocaine 60–100 mg (adjusted for height)

surgical approach

not reported

postoperative pain management

group D:

diclofenac suppository 100 mg after surgery followed by 3 other identical doses at 8 h intervals

group P:

pethidine 1 mg/kg IM after surgery followed by other three doses at 8 h intervals

supplemental analgesia

pethidine 1 mg/kg as needed

 

 

postoperative pain [VAS]: mean ± SD

at 2 h

group D: 6.8 ± 2.3

group P: 7.3 ± 2.4

(p=NS)

at 10 h

group D: 2.05 ± 2.07

group P: 2.6 ± 2.2

(p<0.05)

at 18 h

group D: 1.4 ± 1.6

group P: 2.3 ± 2.2

(p<0.05)

at 26 h

group D: 0.5 ± 1.1

group P: 1.3 ± 1.9

(p<0.05)

satisfaction for pain relief

good: n (%)

group D: 85 (70.8)

group P: 73 (60)

(p=NS)

moderate: n (%)

group D: 31 (25.8)

group P: 36 (30)

(p=NS)

poor: n (%)

group D: 4 (3.3)

group P: 11 (9.2)

(p=NS)

adverse effects/ events

headache: n (%)

group D: 1 (0.8)

group P: 2 (1.6)

(p=NS)

dizziness: n (%)

group D: 0 (0)

group P: 11 (9.1)

(p<0.05)

PONV

similar between groups (not specified)

(p=NS)

methodological shortcomings

– allocation concealment not reported

– no blinding

– no sample size calculation

level of evidence: 2

authors’ conclusion

“Pethidine is one of the most effective opioids for pain relief after caesarean section, but general concerns have been raised for its wide side effects, high cost, and legal issues. It seems that diclofenac suppository is a suitable replacement for this drug because it has shown better analgesic effects on postoperative pain.”

Sun 1990

Diclofenac sodium and low dose epidural morphine for postcesarean analgesia.

 

Anaesthesiologica Sinica, 1990. 28(3): p. 295-301.

 

inclusion criteria

– ASA physical status I/II

exclusion criteria

– allergy history to NSAIDs

– abnormal bleeding tendency

– history of peptic ulceration

– multiple pregnancy

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SEM

group D: 29.52 ± 0.73

group P: 31.32 ± 0.78

maternal weight [kg]: mean ± SEM

group D: 68.30 ± 4.57

group P: 65.71 ± 1.42

maternal height [kg]: mean ± SEM

group D: 156.50 ± 1.27

group P: 157.77 ± 1.18

parity: primiparas n/ multiparas n

group D: 10/ 15

group P: 7/ 18

patient flow and follow up:

total patient number included:

50

randomised in:

group D: 25

group P: 25

excluded:

0

analysed:

all included patients analysed

follow-up:

24 hours

premedication

lactated Ringer’s solution 750 mL

mode of anaesthesia

EA: 2% lidocaine added 1:200 000 epinephrine, gradual lidocaine topping-up

30 min after last supplemental lidocaine, morphine HCl 2 mg in saline 10 mL given epidurally

surgical approach

not reported

postoperative pain management

group D:

diclofenac sodium 75 mg deep gluteal muscle injection

group P:

normal saline 3 mL

rescue analgesia

meperidine 25 mg IV at the recovery room and

 

postoperative pain: mean ± SEM

                        group D                        group P

baseline            3.08 ± 0.31        2.96 ± 0.28

2 h                    2.08 ± 0.44        2.80 ± 0.47

4 h                    1.84 ± 0.35        3.02 ± 0.45*

8 h                    0.40 ± 0.16        1.80 ± 0.29**

12 h                  0.40 ± 0.16        2.24 ± 0.33**

18 h                  0.80 ± 0.27        2.82 ± 0.45**

24 h                  1.92 ± 0.45        4.30 ± 0.60**

(*p=0.064; p**<0.005)

adverse effects/ events

                                group D          group P

nausea/vomiting            13                     9

itching                          25                     25

respiratory depression   0                      0

hematoma/ bleeding      0                      0

rescue analgesia           1                      2

(p=NS)

methodological shortcomings

– generation of allocation sequence not reported

– allocation concealment not reported

–  no sample size calculation

level of evidence: 1

authors’ conclusion

“… with the addition of diclofenac, a potent NSAID, to low dose epidural morphine, the post-caesarean analgesic quality and duration can be greatly improved”

Sun 1992

Combination of low-dose epidural morphine and intramuscular diclofenac sodium in postcesarean analgesia.

 

Anesthesia and Analgesia, 1992. 75(1): p. 64-68.

 

 

inclusion criteria

– ASA physical status I/II

exclusion criteria

– bronchial asthma

– severe liver or kidney diseases

– peptic ulcer

. abnormal bleeding tendency

– known history of allergy to NSAIDs

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SEM

group A: 31 ± 1

group B: 30 ± 1

group C: 31 ± 1

group D: 30 ± 1

maternal weight [kg]: mean ± SEM

group A: 67.4 ± 1.1

group B: 69.1 ± 2.0

group C: 65.9 ± 1.5

group D: 66.5 ± 1.3

maternal height [kg]: mean ± SEM

group A: 157.3 ± 1.0

group B: 157.4 ± 1.0

group C: 157.2 ± 0.9

group D: 157.2 ± 0.9

parity: primiparas n/ multiparas n

group A: 10/ 19

group B: 11/ 18

group C: 10/ 19

group D: 13/ 17

patient flow and follow up:

total patient number included:

120

randomised in:

group A: 30

group B: 30

group C: 30

group D: 30

excluded: 3

owing to severe uterine contraction pain:

group A: 1

group B: 1

group C: 1

analysed:

group A: 29

group B: 29

group C: 29

group D: 30

follow-up:

24 hours

premedication

lactated Ringer’s solution 750 mL

mode of anaesthesia

EA: 2% lidocaine with freshly added epinephrine 1:200 000

surgical approach

not reported

after delivering

oxytocin 10 U and ergonovine 0.2 mg IV

postoperative pain management

group A:

epidural saline (10 mL)

and saline solution (3 mL) IM

group B:

epidural saline (10 mL)

and diclofenac 75 mg (3 mL) IM

group C:

epidural morphine 2 mg (10 mL)

and saline solution (3 mL) IM

group D:

epidural morphine 2 mg (10 mL)

and diclofenac 75 mg (3 mL) IM

rescue analgesia

meperidine 50 mg IV every 4 h at request

 

postoperative incisional pain:

group C versus group D

significantly reduced in group D only at 12 h

(p<0.05)

group B versus group D

significantly reduced in group D at 4, 8, 12 and 18 h

(p<0.05)

group B versus group C

significantly reduced in group B at 4, 8 and 12 h

(p<0.05)

group A versus group B

significantly reduced in group B at 12 and 18 h

(p<0.05)

postoperative uterine contraction pain:

group C versus group D

significantly reduced in group D only at 4, 8, 12 and 18 h

(p<0.05)

group B versus group D

significantly reduced in group D only at 4, 8, 12 and 18 h

(p<0.05)

group B versus group C

significantly reduced in group C only at 4, 8, 12 and 18 h

(p<0.05)

group A versus group B

significantly reduced in group B only at 4, 8, 12 and 18 h

(p<0.05)

patient satisfaction

significantly superior in group D compared with group A, group B and group C

(p<0.05)

no significant differences among the latter three groups

meperidine consumption [mg]

group A: 3650

group B: 2450

group C: 400

group D: 0

groups A and B required significantly more rescue analgesia than groups C and D

adverse effects/ events

PONV

group A: 3

group B: 6

group C: 10

group D: 12

(p<0.05)

pruritus

group A: 0

group B: 1

group C: 27

group D: 30

(p<0.05)

bleeding

group A: 1

group B: 1

group C: 1

group D: 0

(p=NS)

bradypnea

group A: 0

group B: 0

group C: 0

group D: 0

(p=NS)

 

methodological shortcomings

– generation of allocation sequence not reported

– allocation concealment not reported

–  no sample size calculation

level of evidence: 1

authors’ conclusion

“… diclofenac sodium alone is not adequate for post-caesarean analgesia. Although effective in relieving most wound pain, 2 mg of epidural morphine is not fully effective in relieving uterine contraction pain. The combination of low-dose (2 mg) epidural morphine and 75 mg of IM diclofenac sodium enhances the analgesic effect in the treatment of both wound pain and uterine cramps after caesarean section.”

Surakarn 2009

Intramuscular diclofenac for analgesia after cesarean delivery: A randomized controlled trial.

 

Journal of the Medical Association of Thailand, 2009. 92(6): p. 733-737.

inclusion criteria

– single viable fetus in cephalic presentation

– no history of NSAIDs allergy or contraindication

exclusion criteria

– operative time >2 h

– intraoperative blood loss >1000 mL

– injury to bowel or bladder

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group D: 29.6 ± 5.19

group P: 30.8 ± 4.82

parity: nulliparas n (%)/ multiparas n (%)

group D: 12 (30)/ 28 (70)

group P: 6 (15)/ 34 (85)

repeat caesarean section: n (%)

group D: 26 (65)

group P: 34 (85)

patient flow and follow up:

total patient number included:

80

randomised in:

group D: 40

group P: 40

excluded:

0

analysed:

all included patients analysed

follow-up:

48 hours

mode of anaesthesia

SpA: hyperbaric bupivacaine 10–12 mg with morphine 0.2 mg

surgical approach

low transverse caesarean section with low midline incision

postoperative pain management

group D:

diclofenac sodium 75 mg IM postoperatively within 2 h and then at 12 h (altogether 2 doses)

group P:

no intervention

rescue analgesia

tramadol 50 mg IM

 

postoperative pain [VAS]: median (range)

at 6 h

group D: 1 (0–6)

group P: 4 (0–6)

(p=0.002)

at 12 h

group D: 2 (0–5)

group P: 3 (0–7)

(p=0.031)

at 24 h

group D: 1.5 (0–4)

group P: 3 (1–8)

(p<0.001)

at 48 h

group D: 3 (0–4)

group P: 3 (1–8)

(p=0.136)

rescue analgesia: n (%)

group D: 0 (0)

group P: 8 (20)

(0.003)

patient satisfaction: mean ± SD

at 24 h

group D: 4.33 ± 0.52

group P: 4.05 ± 0.59

(p=0.073)

at 48 h

group D: 4.00 ± 0.50

group P: 4.25 ± 0.54

(p=0.12)

adverse effects/ events

no occurrence of

– gastrointestinal bleeding

– bleeding tendency

– uterine atony

– injection site irritation

– anaphylaxis

 

methodological shortcomings

– no blinding

– selective outcome reporting unclear

level of evidence: 1

authors’ conclusion

“… diclofenac can be prescribed in postoperative caesarean pain control with effectiveness and safety when wishing to avoid opioids and its derivatives because of side effects.”

Gin 1993

Analgesia after caesarean section with intramuscular ketorolac or pethidine.

 

Anaesthesia and Intensive Care, 1993. 21(4): p. 420-423.

 

inclusion criteria

– ASA physical status I/II Asian women

– general anaesthesia

– uncomplicated term pregnancies

– will bottle-feed their babies

– moderate or severe pain and requesting analgesia

exclusion criteria

– mild, or very severe pain

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SEM

group K: 31.5 ± 4.4

group P: 31.4 ± 3.9

height [cm]: mean ± SEM

group K: 153 ± 5.8

group P: 154 ± 6.0

weight [kg]: mean ± SEM

group K: 62.6 ± 7.6

group P: 64.8 ± 8.0

patient flow and follow up:

total patient number included:

100

randomised in:

group K: 49

group P: 51

excluded:

0

analysed:

all patients

follow-up:

24 hours

mode of anaesthesia

GA: induced with thiopentone 4–5 mg/kg, suxamethonium 1.5 mg/kg,

maintained with atracurium, nitous oxide and isoflurane

surgical approach

not reported

at the end of surgery

fentanyl 100 µg and oxytocin 10 mg, neuromuscular block was antagonised with neostigmine, atropine

postoperative pain management

in recovery room:

group K:

ketorolac 30 mg IM

group P:

pethidine 75 mg IM

supplemental analgesia

pethidine 75 mg IM as needed

postoperative pain

VAS

no difference between the groups

(p=NS)

assessment of overall pain: group K n/ group P n

no analgesia: 6/ 6

some: 21/ 23

marked: 21/ 22

complete: 1/ 0

(p=NS)

supplemental analgesia: n

time to first request

similar in both groups

(p=0.27)

not necessary in:

group K: 4

group P: 6

overall opinion of study drug: group K n/ group P n

poor: 8/ 5

fair: 12/ 18

good: 25/ 23

very good: 4/ 4

adverse effects/ events

group K

one patient with dizziness, nausea and vomiting

group P

nine patients (6 nausea, 2 dizziness, 1 nausea, vomiting and dizziness)

(p<0.05)

methodological shortcomings

– generation of allocation sequence not reported

– allocation concealment not reported

– unclear blinding of participants and personnel

– method of blinding not described

– no sample size calculation

level of evidence: 1

authors’ conclusion

“…ketorolac 30 mg and pethidine 75 mg have similar, short but variable efficacy after caesarean section. We consider the administration of either drug by the intramuscular route as generally unsatisfactory and unsuitable for the initial treatment of patients with severe pain when the intravenous route is available. Analgesic regimens should be individualised, and provided that effective e analgesia is achieved immediately after surgery, we expect intramuscular ketorolac to be an alternative to intramuscular pethidine for further routine analgesia on the ward. Ketorolac should have fewer logistic problems associated with its administration because it is not subject to the strict regulations governing opioid drugs. Ketorolac also has a lower incidence of side-effects compared with pethidine but studies are still required to determine whether ketorolac is cost-effective.”

Alhashemi 2006

Intravenous acetaminophen vs oral ibuprofen in combination with morphine PCIA after Cesarean delivery

 

Canadian Journal of Anesthesia, 2006. 53(12): p. 1200-1206.

 

inclusion criteria

– >/=37 weeks pregnant

– caesarean section under spinal anaesthesia

exclusion criteria

– abnormally lying placenta

– prenatally diagnosed fetal abnormalities

– intra-uterine fetal death

– hypertensive diseases of pregnancy

– renal impairment

– any contraindication to spinal anaesthesia

– language barrier or mental disorder

– any allergy and/or contraindication to any of the study medications

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group A: 33 ± 5

group I: 32 ± 5

weight [kg]: mean ± SD

group A: 81 ± 16

group I: 78 ± 15

ASA status: [n I]/ [n II]

group A: 12/ 10

group I: 12/ 11

gestational age [weeks]: mean ± SD

group A: 38 ± 1

group I: 38 ± 1

parity

group A: 3 ± 2

group I: 3 ± 2

gravidity

group A: 4 ± 2

group I: 4 ± 2

patient flow and follow up:

total patient number included:

45

randomised in:

group A: 22

group I: 23

excluded:

0

analysed:

group A: 22

group I: 23

follow-up:

48 hours

mode of anaesthesia

– SpA using 2.5 mL of 0.5% hyperbaric bupivacaine mixed with fentanyl 10 µg

surgical approach

horizontal lower segment uterine incision

intraoperative pain

fentanyl 50 µg IV as needed

intra- and postoperative PONV

metoclopramide 10 mg IV every 6 h as needed

postoperative pain management

group A

– paracetamol 1 g (100 mL) IV over 15 min and one placebo tablet PO, each given every 6 h for 48 h

group I

– ibuprofen 400 mg PO and saline 100 mL IV over 15 min, each given every 6 h for 48 h

first administration in both groups 30 min before surgery

PACU

– morphine 0.05 mg/kg IV bolus

– iPCA: morphine bolus dose 2 mg IV, lockout 10 min, no basal infusion

rescue analgesia

– if VAS >/= 5:

morphine 5 mg IV bolus every 4 h as needed

– 48 h after surgery: tramadol 1 mg/kg IM every 4 hours

pain scores at rest

no significant differences

(p=0.143)

iPCA morphine consumption [mg]: mean ± SD

no significant differences

(p=0.562)

rescue morphine [n]

group A: 1

group I: 2

(p=1.0)

APGAR-Score

no significant differences between the groups

patient satisfaction with analgesia: mean ± SD

group A: 9 ± 1

group I: 9 ± 1

(p=0.93)

adverse effects/ events

no significant differences between the groups in:

– PONV

– respiratory depression

– oxygen desaturation

pruritus

group A: 10

group I: 19

(p=0.031)

 

methodological shortcomings

– no methodological shortcomings according to the evaluation sheet

level of evidence: 1

authors’ conclusion

“Intravenous paracetamol is a reasonable alternative to oral ibuprofen as an adjunct to morphine patient-controlled analgesia after cesarean delivery”

Carvalho 2006

Valdecoxib for postoperative pain management after cesarean delivery: A randomized, double-blind, placebo-controlled study.

 

Anesthesia and Analgesia, 2006. 103(3): p. 664-670.

inclusion criteria

– ASA physical status I/II

– 18–45 yr

– singleton pregnancy

– gestation >37 wk

– no postpartum tubal ligation

exclusion criteria

– pregnancy-induced hypertension

– renal disorders

– coagulation disorder

– significant  cardiovascular disease

– peptic ulcer disease

– use of narcotic analgesics

– anticonvulsants

– corticosteroids

– antidepressants

– anxiolytics

– NSAIDS <24

– BMI >40

– prior myomectomy or vertical uterine scar

– history of alcohol, analgesic, or narcotic abuse

– any significant antepartum, intrapartum, or postpartum haemorrhage

– inadequate intraoperative neuraxial anaesthesia requiring conversion

– previous breast surgery or other breast problems resulting in inability to breast-feed

– allergies to sulfa, opioid or NSAID medications

– NSAID-sensitive asthmatics

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group V: 34 ± 6

group P: 34 ± 5

height [cm]: mean ± SD

group V: 157 ± 6

group P: 160 ± 6

weight [kg]: mean ± SD

group V: 74 ± 8

group P: 79 ± 12

nullipara: n (%)

group V: 5 (20)

group P: 5 (22)

previous caesarean deliveries: n (%)

group V: 18 (72)

group P: 17 (74)

patient flow and follow up:

total patient number included:

48

randomised in:

group V: 25

group P: 23

withdrawn:

group V: 1 for administering NSAIDs

excluded

0

analysed:

all patients

follow-up:

72 hours

mode of anaesthesia

SpA: hyperbaric bupivacaine 12 mg fentanyl 10 µg, morphine 100 µg IT

surgical approach

not reported

postoperative pain management

group V:

valdecoxib PO 20 mg twice daily for 72 h, first dose 90 min after spinal block

group P:

placebo at the same point in time as valdecoxib was given

supplemental analgesia

mild pain: VPS<3

1 tablet (hydrocodone 5 mg or oxycodone 5 mg) every 4 h as needed

moderate pain: VPS 3–7

2 tablets (hydrocodone 10 mg or oxycodone 10 mg) every 4 h as needed

severe pain: VPS >7 or moderate pain not responsive to oral analgesics

morphine 2–4 mg IV every 10 min as necessary until comfortable (<10 mg/h)

max. doses allowed were oxycodone 60 mg or hydrocodone 60 mg or 4 g paracetamol (in combination with the oral opioid) in a 24 h period

 

postoperative pain [VPS]

pain at rest during 72 h

no significant differences between the two groups

(p=0.37)

pain on movement during 72 h

no significant differences between the two groups

(p=0.42)

time to first analgesic request [min]: mean ± SD

group V: 335 ± 204

group P: 364 ± 189

(p=0.68)

supplemental analgesia

total IV morphine [mg]: mean ± SD

group V: 3 ± 4

group P: 2 ± 3

(p=0.42)

total analgesic use (morphine-equivalent) [mg]: mean SD

group V: 121 ± 70

group P: 143 ± 77

(p=0.26)

adverse effects/ events

no significant differences between groups in:

– vaginal bleeding

– hypertension

– sedation

– pruritus

– nausea

methodological shortcomings

no methodological shortcomings according to the evaluation sheet.

“However, because of concerns about the safety of COX-2 inhibitors that became apparent from published reports during this study, a decision was made to terminate the study early until the safety concerns were better understood”

level of evidence: 1

 

authors’ conclusion

“… were unable to demonstrate significant analgesic efficacy of valdecoxib compared with placebo. Patients did not experience any adverse events related to short-term postoperative administration of valdecoxib. In light of the lack of significant analgesic efficacy observed and the potential thrombotic cardiovascular risks associated with valdecoxib, its routine use in the management of pain after caesarean delivery is not supported at this time..”

 

reference participants’ characteristics intervention group/ control group

 

outcomes critical appraisal/ conclusion
Bauchat 2011

Low-dose ketamine with multimodal postcesarean delivery analgesia: A randomized controlled trial.

 

International Journal of Obstetric Anesthesia, 2011. 20(1): p. 3-9.

inclusion criteria

– >/=37 weeks of gestation

– ASA physical status I–II

– spinal anaesthesia

exclusion criteria

– BMI >/=40 kg/m²

– allergies to any of the study medications

– contraindication to spinal anaesthesia

– history of hallucinations

– substance abuse

– chronic opioid therapy or chronic pain

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: median [IQR]

group K: 34 [31–37]

group P: 34 [31–37]

weight [kg]: median [IQR]

group K: 77 [71–87]

group P: 77 [70–85]

BMI: median [IQR]

group K: 29 [27–31]

group P: 29 [26–32]

gestational age [week]: median [IQR]

group K: 39 [39–39]

group P: 39 [39–39]

prior caesarean deliveries: n (%)

group K: 59 (69)

group P: 59 (66)

patient flow and follow up:

total patient number included:

188

randomised in:

group K: 94

group P: 94

excluded:

group K: 5

group P: 3

loss to follow up:

group K: 1
group P: 1

excluded from analyses:
group K: 3
group P: 1

analysed:

group K: 85

group P: 89

follow-up:

2 weeks

mode of anaesthesia

SpA: hyperbaric bupivacaine 12 mg (1.6 mL 0.75% bupivacaine in 5% dextrose), fentanyl 15 µg and morphine 150 µg as single injection

surgical approach

not reported

postoperative pain management

five minutes after delivery

group K

ketamine 10 mg IV diluted to 20 mL with 0.9% saline

group P

20 mL of 0.9% saline

administered over 10 min via infusion pump (2 mL/min)

in PACU

ketorolac 30 mg IV every 6 h for 24 h, but patients could refuse this analgesic intervention

rescue medication

the first 24 h

1 tablet of paracetamol 325 mg/hydrocodone 10 mg every 4 h as needed

due to insufficient pain relief

an additional tablet could be provided after 1 h

between 24 and 72 h

ibuprofen 600 mg every 6 h and 1–2 tablets of paracetamol 325 mg/hydrocodone 10 mg every 4 h

 

postoperative pain

pain scores in the first 24 h were similar between the groups, but patients in the ketamine group had significantly lower pain scores at 2 weeks compared to the placebo group

(p=0.02)

incidence of breakthrough pain <24 h: n (%)

group K: 64 (75)

group P: 66 (74)

(p=0.86)

NRS for pain at first analgesic request: median (IQR)

group K: 3 (2–4)

group P: 4 (2–5)

(p=0.02)

time to first analgesic request [min]: median (95%-CI)

group K: 684 (337,1031)

group P: 760 (346,1174)

(p=0.65)

cumulative paracetamol/ hydrocodone tablets: median (IQR)

24 h

group K: 2 (1–4)

group P: 1 (0–3)

(p=0.22)

48 h

group K: 6 (4–9)

group P: 5 (3–8)

(p=0.11)

72 h

group K: 10 (6–14)

group P: 9 (5–12)

(p=0.24)

cumulative ibuprofen dose [mg]: median (IQR)

group K: 3600 (1200–4200)

group P: 3600 (2400–4200)

(p=0.28)

satisfaction with analgesia: median (IQR)

24 h

group K: 9 (8–10)

group P: 9 (8–10)

72 h

group K: 9 (8–10)

group P: 9 (8–10)

adverse effects/ events

no significant differences between groups in:

nausea: n (%)

group K: 27 (32)

group P: 30 (23)

(p=0.87)

vomiting: n (%)

group K: 13 (15)

group P: 13 (15)

(p=0.90)

pruritus: n (%)

group K: 12 (14)

group P: 19 (21)

(p=0.24)

 

methodological shortcomings

– no methodological shortcomings according to the evaluation sheet

level of evidence: 1

authors’ conclusion

“… no additional postoperative analgesic benefit of low-dose ketamine during caesarean delivery in patients who received intrathecal morphine and intravenous ketorolac. Subjects who received ketamine reported lower pain scores 2 weeks postpartum.

Bilgen 2012

Effect of three different doses of ketamine prior to general anaesthesia on postoperative pain following Caesarean delivery: a prospective randomized study.

 

Minerva Anestesiol, 2012. 78(4): p. 442-9.

 

inclusion criteria

– ASA physical status I/ II

– nulliparous women

– caesarean section indicated

exclusion criteria

– pre-eclampsia

– cardiovascular problems

– allergy to any of the study medications

– chronic preoperative pain

– regular analgesic use

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group KL: 30 ± 3

group KM: 31 ± 4

group KH: 32 ± 4

group P: 32 ± 4

maternal weight [kg]: mean ± SD

group KL: 78 ± 9

group KM: 77 ± 9

group KH: 77 ± 10

group P: 82 ± 15

patient flow and follow up:

total patient number included:

140

randomised in:

group KL: 35

group KM: 35

group KH: 35

group P: 35

excluded:

0

analysed:

all randomised patients analysed

follow-up:

48 hours/ 1 year

before anaesthesia

IV administration of study drugs:

group KL:

ketamine 0.25 mg/kg

group KM:

ketamine 0.5 mg/kg

group KH:

ketamine 1 mg/kg

group P:

placebo (0.9% saline)

mode of anaesthesia

GA:

induced with:

propofol 2–2.5 mg/kg

maintained with:

50% oxygen in N2O and

sevoflurane

surgical approach

Pfannenstiel incision

postoperative pain management

after delivery

IV infusion of 20 IU oxytocin,

IV morphine chloride 0.1 mg/kg,

IV lornoxicam 8 mg

if NRS>4 in PACU:

IV morphine </=0.05 mg/kg

supplemental analgesia

IV morphine chloride via PCA (0.5 mg/mL),

(1 mg bolus, 10 min lock-out time, without basal infusion)

rescue analgesia

IM diclofenac sodium 75 mg every 12 h as needed

pain at rest [NRS]

up to 48 h

no significant differences between groups

prolonged postoperative pain

no significant differences at 2 weeks, 1 month, 6 month and 12 months

morphine consumption via PCA

similar between the groups during 48 h

need for rescue analgesia: n

group KL: 8

group KM: 11

group KH: 7

group P: 14

(p-value not reported)

Apgar score

at 1 min

group KL: 8.3 ± 1

group KM: 8.2 ± 1

group KH: 8.0 ± 1

group P: 8.0 ± 1

(p=0.05)

at 5 min

group KL: 9.6 ± 0.5

group KM: 9.5 ± 0.7

group KH: 9.5 ± 0.6

group P: 9.5 ± 0.7

(p=0.05)

adverse effects/ events

no significant differences between groups in:

– nausea

– vomiting

– nystagmus

– hallucination

– diplopia

– sedation

methodological shortcomings

– allocation concealment not reported

level of evidence: 1

authors’ conclusion

“No benefit was observed when ketamine was used as an analgesic drug in doses of 1 mg/kg or lower, with respect to postoperative pain reduction, as well the quality of our anaesthesia was not improved. We had comparable hemodynamic parameters in all groups. Therefore this topic needs further evaluation with studies assessing the plasma concentrations of ketamine.”

Menkiti 2012

Low-dose intravenous ketamine improves postoperative analgesia after caesarean delivery with spinal bupivacaine in African parturients.

 

Int J Obstet Anesth, 2012. 21(3): p. 217-21.

 

inclusion criteria

– ASA physical status I/ II

exclusion criteria

– pre-existing neurological disease

– evidence of fetal compromise

– patient refusal

– coagulopathy

– thrombocytopenia

– infection at the puncture site

– previous history of reaction to local anaesthetic agents

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group B: 29.8 ± 3.1

group BK: 30.3 ± 4.0

maternal height [cm]: mean ± SD

group B: 161 ± 12

group BK: 164 ± 3

maternal weight [kg]: mean ± SD

group B: 72.2 ± 5.0

group BK: 73.7 ± 6.2

parity: median [range]

group B: 0 [0–4]

group BK: 0 [0–4]

gestational age [wk.]: mean SD

group B: 38.3 ± 1.0

group BK: 38.3 ± 0.9

patient flow and follow up:

total patient number included:

60

randomised in:

group B: 30

group BK: 30

excluded: 4

group B: 2

– failed block (1)

– conversion to GA (1)

group BK: 2

– severe intraoperative shivering (2)

analysed: 56

group B: 28

group BK: 28

follow-up:

48 hours

before anaesthesia

IV 0.9% saline 20 mL/kg

mode of anaesthesia

SpA: 0.5% hyperbaric bupivacaine 15 mg

after institution of SpA

group B:

IV 0.9% saline

group BK:

IV ketamine 0.15 mg/kg

surgical approach

not reported

postoperative pain management

rescue analgesia: VAS score >3

IM diclofenac 75 mg and pentazocine 30 mg

thereafter:

IM pentazocine 30 mg/4 h and diclofenac 75 mg/8 h if requested

pain VAS:

higher in group B at 60, 90 and 120 min, but not at 30 min

(p<0.05)

Apgar score: median [range]

at 1 min

group B: 9 [7–10]

group BK: 9 [8–9]

(p-value not reported)

at 5 min

group B: 10 [8–9]

group BK: 10 [9–10]

(p-value not reported)

time to first analgesic request [min]: mean ± SD

group B: 164 ± 14.1

group BK: 209 ± 14.7

(p<0.001)

analgesic requirements

total diclofenac dose

group B           group BK          p-value

day 1    212 ± 29.2      147 ± 24.9         <0.001

day 2    137 ± 41.1      126 ± 35.7         0.3

total pentazocine dose

group B           group BK         p-value

day 1    150 ± 20.0     109 ± 18.6         <0.001

day 2    102 ± 18.9      99 ± 16.4           0.092

adverse effects/ events

no significant differences between groups in:

– hypotension

– shivering

– nausea

– sedation

– vomiting

– headache

– hallucination

– blurred vision

methodological shortcomings

– no sample size calculation

level of evidence: 1

authors’ conclusion

“… administration of 0.15 mg/kg intravenous ketamine as an adjuvant to intrathecal bupivacaine for cesarean delivery improved postoperative analgesia and reduced cumulative analgesic administration on the first day after cesarean delivery. There were no significant side effects, and neonatal outcome was not affected.”

Reza 2010

Preemptive analgesic effect of ketamine in patients undergoing elective cesarean section.

 

Clin J Pain, 2010. 26(3): p. 223-6.

 

 

inclusion criteria

– ASA physical status I/ II

– general anaesthesia

exclusion criteria

– allergy to ketamine, thiopental, or morphine

– history of substance abuse

– pregnancy-induced hypertension

– transverse or breach positions

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group K: 26.96 ± 5.1

group P: 27.33 ± 4.54

maternal weight [kg]: mean ± SD

group K: 71.54 ± 12.3

group P: 73.34 ± 13.4

patient flow and follow up:

total patient number included:

60

randomised in:

group K: 30

group P: 30

excluded:

0

analysed:

all randomised patient analysed

follow-up:

24 hours

before anaesthesia

Ringer solution 500 mL

group K:

IV ketamine 0.5 mg/kg (diluted to 10 mL with normal saline)

group P:

saline 10 mL

mode of anaesthesia

GA:

induced with:

thiopental 4 mg/kg followed by succinylcholine 1.5 mg/kg

maintained with:

nitrous oxide (50%) and halothane in oxygen

surgical approach

not reported

postoperative pain management

after delivery

10 IU of oxytocin, IV fentanyl 2 µg/kg, IV morphine 0.15 mg/kg

after surgery

rectal diclofenac 200 mg

in PACU

if VAS </=3:

no morphine

if VAS 4-6:

IV morphine 3 mg

if VAS >/=7:

IV morphine 5 mg

in the ward

rectal diclofenac 100 mg every 4 h

if VAS >/=4:

IM morphine 0.15 mg/kg

 

pain [VAS]

no significant differences between groups at 2, 6, 12 and 24 h

morphine consumption

0–2 h

lower in group K

(p<0.01)

2–24 h

no significant difference

Apgar score: mean ± SD

at 1 min

group K: 8.64 ± 0.75

group P: 8.57 ± 1.02

(p-value not reported)

at 5 min

group K: 9.96 ± 0.2

group P: 9.93 ± 0.24

(p-value not reported)

adverse effects/ events

no significant differences between groups in:

– hallucination

– delirium

– recall intraoperative events

– unpleasant dreams

– nausea

– vomiting

methodological shortcomings

– no methodological shortcomings according to the evaluation sheet

level of evidence: 1

authors’ conclusion

“…small doses of ketamine reduced by 40% the use of morphine during the first 2 hours after surgery, but no difference was found over 24 hours. Side effects were similar in the 2 groups, and pain scores were identical. Therefore, we believe that any preemptive effect of ketamine is likely to depend on the intensity of the noxious stimulus, the dose of ketamine used, and the types of adjuvant drugs administered. This remains to be worked out in further research.”

Sen 2005

The persisting analgesic effect of low-dose intravenous ketamine after spinal anaesthesia for caesarean section.

 

Eur J Anaesthesiol, 2005. 22(7): p. 518-23.

 

 

inclusion criteria

– ASA physical status I/ II

exclusion criteria

– coexisting diseases (pregnancy-induced hypertension and gestational diabetes)

– fetal compromise

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group F: 28.5 ± 5.1

group K: 26.3 ± 5.3

group P: 27.1 ± 4.6

maternal height [cm]: mean ± SD

group F: 158.3 ± 7.6

group K: 162.0 ± 6.1

group P: 160.0 ± 5.2

maternal weight [kg]: mean ± SD

group F: 76.7 ± 8.5

group K: 78.1 ± 7.8

group P: 73.2 ± 9.4

gestational age [wk.]: mean ± SD

group F: 39.3 ± 1.9

group K: 39.1 ± 1.6

group P: 38.2 ± 1.8

patient flow and follow up:

total patient number included:

90

randomised in:

group F: 30

group K: 30

group P: 30

excluded:

0

analysed:

all randomised patient analysed

follow-up:

48 hours

mode of anaesthesia

SpA: bupivacaine 15 mg combined with:

group F:

IT fentanyl 10 µg

group K:

IV ketamine 0.15 mg/kg

group P:

saline

surgical approach

not reported

postoperative pain management

in PACU

if VAS >3

IM diclofenac sodium 75 mg

supplemental analgesia

diclofenac

time to first analgesic request [min]: mean ± SD

group F: 165.2 ± 17.1*

group K: 198.6 ± 18.9**

group P: 144.8 ± 15.2

* p=0.034 group F versus group P

** p=0.001 group K versus group P

pain [VAS]

                         group F      group K       group P:

30 min              0                0                 0

60 min              0                0                 0

90 min             1.2 ± 0.7    0*                 2.4 ± 0.8

120 min           2.3 ± 0.8    1.4 ± 0.8      3.1 ± 1.0

150 min           3.0 ± 0.9    2.2 ± 1.0      5.6 ± 1.5**

180 min           5.4 ± 1.7    3.5 ± 1.2*    6.0 ± 1.8

* (p<0.05) for group K versus group P and group F

** (p<0.05) for group P versus group K and group F

diclofenac consumption [mg]: mean ± SD

0–24 h

group F: 185.6 ± 30

group K: 117.5 ± 27*

group P: 225.4 ± 28

* p<0.05 for group K versus group F and group P

24–48 h

group F: 128.3 ± 22

group K: 124.5 ± 25

group P: 137.2 ± 24

(p=NS)

Apgar score: mean

at 1 min

group F: 10 (9–10)

group K: 9 (8–10)

group P: 9 (8–10)

(p-value not reported)

at 5 min

group F: 10 (9–10)

group K: 10 (9–10)

group P: 10 (9–10)

(p-value not reported)

adverse effects/ events

no significant differences between groups in:

– nausea

– sedation

– pruritus

– postdural puncture headache

– total complicaton

methodological shortcomings

– allocation concealment not reported

level of evidence: 1

authors’ conclusion

“… the combination of IV low-dose ketamine and intathecal bupivacaine results in lower postoperative analgesic consumption and lower VAS scores compared to bupivacaine alone or the combination of bupivacaine and intrathecal fentanyl after caesarean section suggesting a pre-emptive analgesic effect.”

Ghazi-Saidi 2002

Effects of preemptive ketamine on post-cesarean analgesic requirement

 

Acta Medica Iranica, Vol 40, No 2 (2002)

inclusion criteria

– ASA physical status I/ II

– general anaesthesia

exclusion criteria

– allergy to either of thiopental, ketamine, morphine

– gestational age <36 weeks

– fetal distress

– candidate for classical caesarean incision

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group K: 28.66 ± 5.25

group P: 27.07 ± 3.28

(p=0.195)

maternal weight [kg]: mean ± SD

group K: 74.48 ± 12.49

group P: 67.16 ± 10.31

(p=0.026)

gestational age [wk.]: mean

group K: 39.92

group P: 39.72

patient flow and follow up:

total patient number included:

53

randomised in:

group K: 27

group P: 26

excluded:

0

analysed:

all randomised patient analysed

follow-up:

24 hours

before anaesthesia

group K:

IV ketamine 0.2 mg/kg

group P:

distilled water

mode of anaesthesia

GA

induced with:

thiopental 5%,

succinylcholine 1.5 mg/kg

maintained with:

halothan 0.5%, 50% nitrous oxide in oxygen

surgical approach

not reported

after delivery

5 IU oxytocin, morphine 0.1 mg/kg and midazolam 1 mg (as bolus IV),

in addition 10 IU oxytocin

intravenously

postoperative analgesia

if NRS </=3

no morphine

if NRS between 4 and 6:

morphine 3 mg

if NRS >/=7

morphine 5 mg

postoperative pain [NRS or FRS] during first 24 h

higher in group P

(p<0.001)

time to first analgesic request [h]: mean ± SD

group K: 10.22 ± 8

group P: 1.65 ± 1.01

(p<0.001)

total morphine consumption [mg]: mean ± SD

group K: 6.25 ± 3.42

group P: 17.73 ± 4.08

(p<0.001)

Apgar score

no significant differences between the groups at 1 and 5 min

adverse effects/ events

not reported

methodological shortcomings

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“…ketamine in analgesic dose (0.2 mg/kg), given before induction of general anesthesia in cesarean patients, has a preemptive analgesia effect that prevents central sensitization. It may also reverse the established central sensitization in patients who have had experienced labour pain. These altogether, cause much reduction in postoperative analgesic requirements.”

Han 2013

The effect of low-dose ketamine on post-caesarean delivery analgesia after spinal anesthesia

 

Korean J Pain 26(3): 270-276.

 

inclusion criteria

– ASA physical status I/ II

– between 37–42 wk.

– spinal anaesthesia

exclusion criteria

– psychological diseases

– difficulties communicating

– allergies to local anaesthesia

– inflammation in the spinal puncture area

– coagulation disorder

– administered analgesics

– emergency operation

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group K: 32.7 ± 3.7

group P: 32.5 ± 3.6

maternal height [cm]: mean ± SD

group K: 159.1 ± 6.8

group P: 159.0 ± 4.3

maternal weight [kg]: mean ± SD

group K: 68.4 ± 11.7

group P: 69.1 ± 11.4

gestational age [wk.]: mean ± SD

group K: 38.5 ± 1.9

group P: 39.2 ± 1.8

patient flow and follow up:

total patient number included:

40

randomised in:

group K: 20

group P: 20

excluded: 4

failed spinal puncture (n=4)

analysed:

group K: 19

group P: 17

follow-up:

not reported

mode of anaesthesia

SpA: 0.5% bupivacaine 10 mg

before incision:

group K:

IV ketamine 0.5 mg/kg followed by continuous infusion of 0.25 mg/kg/h until the end of surgery

group P:

IV saline followed by continuous infusion of saline

surgical approach

not reported

intraoperative pain management

patient’s request or decision of anaesthesiologist:

fentanyl 50 µg (</=2 times)

postoperative pain management

supplemental analgesia

IV fentanyl via PCA:

25 µg/mL, dose 1 mL, lockout 15 min, without continuous dose)

rescue analgesia

VAS >/=5 or patient requested:

IM ketorolac 30 mg

intraoperative need for ketamine [mg]: mean ± SD

group K: 48.5 ± 10.4

group P:49.7 ± 9.2

(p=NS)

intraoperative administration of fentanyl: n

group K: 3

group P: 4

(p=NS)

postoperative pain [VAS]

at rest

no significant differences between the groups at 2, 6, 24 and 48 h

coughing

no significant differences between the groups at 2, 6, 24 and 48 h

fentanyl consumption

significantly lower in group K at 2 h (p=0.033), but not at 6, 24 and 48 h

need for ketorolac: n

group K: 4

group P: 6

(p=NS)

adverse effects/ events

not reported

methodological shortcomings

– allocation concealment not reported

– blinding of outcome assessor not reported

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“…0.5 mg/kg ketamine was injected IV before the skin incision and infused continually at 0.25 mg/kg/h until the end of the operation in pregnant mothers receiving cesarean section under spinal anesthesia, but this treatment did not reduce the fentanyl requirement or postoperative VAS score. Further research is needed regarding the postoperative pain relief effect and complications according to administration time, period, and dosage of ketamine in pregnant mothers receiving cesarean section under spinal anesthesia”

Suppa 2012

A study of low-dose S-ketamine infusion as “preventive” pain treatment for cesarean section with spinal anesthesia: benefits and side effects.

 

Minerva Anestesiol 78(7): 774-781.

inclusion criteria

– elective repeat caesarean section

– spinal anaesthesia

exclusion criteria

– age <18 years or >40 years

– ASA physical status status III–IV

– preexisting neurological or psychiatric illnesses

– pathologic pregnancy

-gestational age <37 weeks

-difficulties in cooperation between physician and patient

– history of chronic pain

– assuming NSAIDs or opioids or opioids addicted

demographic data:

maternal age [yr.]: mean

group K: 34.00

group P: 33.54

maternal weight [kg]: mean

group K: 73.22

group P: 75.04

gestational age [wk.]: mean

group K: 38.44

group P: 38.05

(p=0.004)

parity: n: mean

group K: 2.33

group P: 2.46

patient flow and follow up:

total patient number included:

56

randomised in:

group K: 28

group P: 28

excluded:

0

analysed:

after 24 h

group K: 28

group P: 28

after 3 months

group K: 13

group P: 13

follow-up:

24 h and 3 months

mode of anaesthesia

SpA: 0.5% hyperbaric bupivacaine 8–10 mg and sufentanil 5 µg

surgical approach

not reported

group K

IM S-Ketamine bolus 0.5 mg/kg 10 min after birth followed by 2 µg/kg/min IV continuous infusion for 12 h via infusional pump

group P:

placebo in the same manner

postoperative pain management

IV morphine via PCA </=24 h:

bolus 1 mg, 8 min lock out, </=30 mg/4 h, without continuous infusion

>24 h

oral paracetamol 4 g/day and ketorolac 30–90 mg/day as needed

morphine consumption

significantly reduced in group K at 4–8, 8–12, and 12–24 h, but not before

cumulative morphine consumption [mg]: mean ± SD

at 24 h

group K: 25.33 ± 11.76

group P: 37.00 ± 11.57

(p<0.001)

need for paracetamol and ketorolac

no significant differences between the groups

time to first analgesic request [min]: mean ± SD

group K: 268 ± 158

group P: 190 ± 81.48

(p=0.013)

adverse effects/ events

significantly more frequent in group K:

– drowsiness

– diplopia

– nystagmus

– dizziness

– light-headness

– positive dysphoria

– vomiting

no significant differences between groups in:

– dreaming

– negative dysphoria

– nausea

– pruritus

– hallucinations

follow-up after 3 months (telephone survey)

no significant differences between the groups in:

– residual wound pain

– wound dysesthesia

– pain in other sites

– analgesic drugs for pain in other sites

– improved experience

– breastfeeding duration

methodological shortcomings

– generation of allocation sequence not reported

– allocation concealment not reported

– blinding of outcome assessor not reported

level of evidence: 1

authors’ conclusion

“Preventive S-ketamine, administered by i.m. bolus and continuous i.v. infusion, enhanced the analgesic effect of morphine even after ketamine effect had ceased, suggesting anti-hyperalgesic action of the drug. S-ketamine administration in obstetric patients after cesarean section was safe and did not affect breastfeeding. A benefit of S-ketamine on prevention of postoperative hyperalgesia remains to be demonstrated, probably through studies on larger populations with objective methods of pain and hyperalgesia assessment.”

 

reference participants’ characteristics intervention group/ control group

 

outcomes critical appraisal/ conclusion
McDonnell 2010

A randomised comparison of regular oral oxycodone and intrathecal morphine for post-caesarean analgesia.

 

International Journal of Obstetric Anesthesia, 2010. 19(1): p. 16-23.

inclusion criteria

– ASA physical status I/II

– >/=18 yr.

– consented to combined spinal-epidural anaesthesia

exclusion criteria

– concurrent opioid therapy

– contraindications to combined spinal-epidural anaesthesia

– contraindications to combined spinal-epidural anaesthesia

– contraindication to any of the study medications

– history of preoperative pruritus or nausea

– failure to identify subarachnoid space during surgery

– inadvertent dural puncture with epidural needle

-conversion of spinal to general anaesthesia

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: median (IQR; range)

group M: 32 (28–37; 20–44)

group O: 31 (26–36; 20–42)

height [cm]: median (IQR; range)

group M: 165 (162–170; 152–183)

group O: 165 (158–169; 152–183)

weight [kg]: median (IQR; range)

group M: 86 (73–107; 58–153)

group O: 87 (76–107; 51–157)

parity

group M: 2 (1–2; 0–4)

group O: 1 (1–2; 0–4)

ASA physical status II: n (%)

group M: 21 (38)

group O: 24 (43)

previous caesarean section: median (IQR; range)

group M: 1 (1–2; 0–4)

group O: 1 (0–1; 0–3)

patient flow and follow up:

total patient number included:

120

randomised in:

group M: 60

group O: 60

excluded: 9

group M: 4

– withdrew consent intraoperative: 1

– uncontrolled early postoperative pain: 3

group O: 5

– uncontrolled early postoperative pain: 2

– withdrew consent: 2

– conversion to general anaesthesia: 1

analysed:

group M: 56

group O: 55

follow-up:

48 hours

premedication

oral ranitidine 300 mg on the morning of surgery

mode of anaesthesia

CSEA: hyperbaric bupivacaine 11–12.5 mg combined with fentanyl 15 µg plus 0.2 mL of IT study solution:

group M:

IT morphine 100 µg

group O:

IT placebo

intraoperative pain

epidural lidocaine with adrenaline 1:200,000 if surgery was delayed or intraoperative pain experienced,

dexamethasone 4 mg IV after delivery

surgical approach

not reported

postoperative pain management

all patients

parecoxib 40 mg IV at the end of surgery and 8-hourly oral diclofenac 50 mg starting 12 h postoperatively

group M:

morphine IT 100 µg at the same time as spinal anaesthesia and placebo (0.2 mL) medication orally

group O:

saline placebo 0.2 mL IT and oral oxycodone 20 mg in recovery room, followed by oral oxycodone 10 mg every 6 h plus oral paracetamol 1 g

supplemental analgesia

oral oxycodone 10–15 mg 2-hourly as needed,

additionally, oral tramadol 100 mg for insufficient pain relief (NRS>6)

 

time to first analgesic request [min]: median (IQR, range)

group M: 160 (92–230; 23–1419)

group O: 144 (64–218; 20–1440)

(p=0.597)

additional analgesia requested: n (%)

group M: 35 (63)

group O: 46 (82)

(p=0.034)

additional oxycodone [mg]: median (IQR, range)

group M: 23 (10–35; 5–70)

group O: 25 (10–44; 5–85)

(p=0.953)

additional tramadol [mg]: median (IQR, range)

group M: 100 (100–100; 50–300)

group O: 100 (100–200; 50–500)

(p=0.299)

postoperative pain [NRS]: median (IQR, range)

at rest 6 h/                             on movement 6 h

group M: 2 (0–3; 0–7)         4 (3–6; 0–10)

group O: 2 (1–3; 0–10)       5 (3–7; 1–10)

(p=0.178)                              (p=0.062)

at rest 12 h                            on movement 12 h

group M: 1 (0–2; 0–7)         3 (2–5; 0–8)

group O: 2 (1–3; 0–7)         4 (3–6; 0–8)

(p=0.03)                               (p=0.10)

at rest 18 h                            on movement 18 h

group M: 1 (0–2; 0–6)         3 (2–6; 0–8)

group O: 1 (0–2, 0–5)         3 (2–5; 0–8)

(p=0.589)                              (p=0.852)

at rest 24 h                            on movement 24 h

group M: 1 (0–2; 0–8)         3 (2–5; 0–9)

group O: 1 (0–2; 0–8)         3 (2–5; 0–9)

(p=0.688)                              (p=0.792)

AUC to 24 h: at rest             on movement

group M: 21 (6–35; 0–117)   63 (37–96; 3–132)

group O: 24 (12–39; 0–84)   71 (42–99; 18–135)

(p=0.306)                              (p=0.319)

satisfaction with analgesia (0–10): median (IQR; range)

24h                                         48h

group M: 10 (8–10; 3–10)      9 (8–10; 2–10)

group O: 8 (7–10; 2–10)        9 (8–9; 0–10)

(p=0.01)                                 (p=0.887)

adverse effects/ events

pruritus: n (%)

group M: 48 (87)

group O: 31 (56)

(p=0.001)

nausea

no significant differences between the groups

further adverse effect/ events

no case of respiratory depression and only one urinary retention in group O

methodological shortcomings

– allocation concealment not reported

level of evidence: 1

authors’ conclusion

“… multimodal analgesic regimen based on oral oxycodone confers generally comparable and satisfactory clinical analgesic efficacy and a favourable side-effect profile compared with a multimodal regimen based on intrathecal morphine. An intrathecal morphine-based multimodal regimen appeared with reduced need for rescue analgesia and higher maternal satisfaction scores. We consider that a multimodal oral analgesic regimen including oxycodone, paracetamol, parecoxib and diclofenac is an acceptable approach to post-caesarean analgesia. Further refinements to this technique may improve efficacy and maternal satisfaction. Cost-effectiveness evaluation appears warranted.

reference participants’ characteristics intervention group/ control group

 

outcomes critical appraisal/ conclusion
Gin 1993

Analgesia after caesarean section with intramuscular ketorolac or pethidine.

 

Anaesthesia and Intensive Care, 1993. 21(4): p. 420-423.

 

inclusion criteria

– ASA physical status I/II Asian women

– general anaesthesia

– uncomplicated term pregnancies

– will bottle-feed their babies

– moderate or severe pain and requesting analgesia

exclusion criteria

– mild, or very severe pain

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SEM

group K: 31.5 ± 4.4

group P: 31.4 ± 3.9

height [cm]: mean ± SEM

group K: 153 ± 5.8

group P: 154 ± 6.0

weight [kg]: mean ± SEM

group K: 62.6 ± 7.6

group P: 64.8 ± 8.0

patient flow and follow up:

total patient number included:

100

randomised in:

group K: 49

group P: 51

excluded:

0

analysed:

all patients

follow-up:

24 hours

mode of anaesthesia

GA: induced with thiopentone 4–5 mg/kg, suxamethonium 1.5 mg/kg,

maintained with atracurium, nitous oxide and isoflurane

surgical approach

not reported

at the end of surgery

fentanyl 100 µg and oxytocin 10 mg, neuromuscular block was antagonised with neostigmine, atropine

postoperative pain management

in recovery room:

group K:

ketorolac 30 mg IM

group P:

pethidine 75 mg IM

 

supplemental analgesia

pethidine 75 mg IM as needed

postoperative pain

VAS

no difference between the groups

(p=NS)

assessment of overall pain: group K n/ group P n

no analgesia: 6/ 6

some: 21/ 23

marked: 21/ 22

complete: 1/ 0

(p=NS)

supplemental analgesia: n

time to first request

similar in both groups

(p=0.27)

not necessary in:

group K: 4

group P: 6

overall opinion of study drug: group K n/ group P n

poor: 8/ 5

fair: 12/ 18

good: 25/ 23

very good: 4/ 4

adverse effects/ events

group K

one patient with dizziness, nausea and vomiting

group P

nine patients (6 nausea, 2 dizziness, 1 nausea, vomiting and dizziness)

(p<0.05)

methodological shortcomings

– generation of allocation sequence not reported

– allocation concealment not reported

– unclear blinding of participants and personnel

– method of blinding not described

– no sample size calculation

level of evidence: 1

authors’ conclusion

“…ketorolac 30 mg and pethidine 75 mg have similar, short but variable efficacy after caesarean section. We consider the administration of either drug by the intramuscular route as generally unsatisfactory and unsuitable for the initial treatment of patients with severe pain when the intravenous route is available. Analgesic regimens should be individualised, and provided that effective e analgesia is achieved immediately after surgery, we expect intramuscular ketorolac to be an alternative to intramuscular pethidine for further routine analgesia on the ward. Ketorolac should have fewer logistic problems associated with its administration because it is not subject to the strict regulations governing opioid drugs. Ketorolac also has a lower incidence of side-effects compared with pethidine but studies are still required to determine whether ketorolac is cost-effective.”

Marzida 2009

A randomized controlled study comparing subcutaneous pethidine with oral diclofenac for pain relief after caesarean section.

 

Journal of the University of Malaya Medical Centre, 2009. 12(2): p. 63-69.

 

inclusion criteria

– single fetus

– spinal anaesthesia

exclusion criteria

– <18 yr.

– known contraindication to NSAIDs:

– hypersensitivity

– renal impairment

– bleeding disorders

– gastric problems

– asthmatics

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group P: 30.4 ± 4.4

group D: 31.4 ± 5.6

parity [n]: mean IQR

group P: 2.0 (1.00; 2.75)

group D: 2.5 (1.25; 3.75)

patient flow and follow up:

total patient number included:

40

randomised in:

group P: 20

group D: 20

excluded:

0

analysed: 40

one patient discharged before last evaluation was included in analysis

follow-up:

72 hours

prior to anaesthesia

ranitidine 150 mg PO night  and the morning of surgery, respectively;

sodium citrate 30 mL

mode of anaesthesia

SpA: 0.5% hyperbaric bupivacaine 2–2.5 mL IT,

no additional analgesia was given

surgical approach

not reported

postoperative pain management

after surgery

0.5% plain bupivacaine 20 mL,

rectal diclofenac suppository 50 mg

group P:

subcutaneous pethidine 1 mg/kg before discharged from recovery room,

continued with subcutaneous pethidine 1 mg/kg with metoclopramide 10 mg IM every 8 h for three days

group D:

diclofenac sodium 75 mg PO twice daily, first dose given on the evening of surgery

supplemental analgesia

pethidine 1 mg/kg subcutaneously 3 hourly as needed

 

postoperative pain [VAS]:

no significant differences between the groups

need for supplemental analgesia on day 1: n

group P: 0

group D: 12

(p-value not reported)

satisfaction score

similar between groups on day 1, significantly higher in group D on day 2 and day 3

adverse effects/ events

sedation scores: median (IQR)
day 1
group P: 2 (2, 2)
group D: 0 (0, 2)

(p<0.001)

day 2
group P: 1 (1, 2)
group D: 0 (0, 0)

(p<0.001)

day 3
group P: 0 (0, 1)
group D: 0 (0, 0)

(p=0.024)

no significant differences in:

– PONV (only two women in group P)

methodological shortcomings

– allocation concealment unclear

– no blinding of patients and physicians

level of evidence: 1

authors’ conclusion

“…the use of regular oral diclofenac 75 mg twice daily may not provide comparable pain relief on the first postoperative day, but it provided superior patient satisfaction as compared to the traditional method of subcutaneous pethidine 1 mg/kg. Although offering less than perfect analgesia, oral diclofenac provided comfort to the patients with few side effects and can be monitored on the ward. The use of oral diclofenac 150 mg daily did not seem to have any significant side effects in this group of healthy parturient. Therefore, it is still acceptable to use diclofenac alone as an alternative pain relief following caesarean section, in view of the other benefits of non-opioid analgesics and especially in places where newer techniques are neither possible nor practical. However this is only a pilot study, a bigger sample size would be needed to confirm the findings.”

Soroori 2006

The comparison between suppository diclofenac and pethidine in post-cesarean section pain relief: A randomized controlled clinical trial.

 

Journal of Research in Medical Sciences, 2006. 11(5): p. 292-296.

 

inclusion criteria

– gestational age >28 wk.

– no history of convulsion, drug sensitivity, opioid addiction, epigastric pain and gastrointestinal bleeding

exclusion criteria

– operation time >90 min

– any complication during surgery that needed another operation

– postoperative ileus

– any other state which required administration of other analgesics

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group D: 27.2 ± 6.5

group P: 26.4 ± 5.6

gestational age [wk.]: mean ± SD

group D: 38.8 ± 1.7

group P: 39.1 ± 1.4

parity: single parity [% (n)]/ multiparous [% (n)]

group D: 99 (82.5)/ 21 (17.5)

group P: 109 (90.8)/ 11 (9.2)

previous abortion: 0 [n (%)]/ >/=1 [n (%)]

group D: 105 (87.5)/ 15 (12.5)

group P: 104 (86.7)/ 16 (13.3)

previous C-section: yes [n (%)]/ no [n (%)]

group D: 29 (24.2)/ 91 (75.8)

group P: 25 (20.8)/ 95 (79.2)

patient flow and follow up:

total patient number included:

240

randomised in:

group D: 120

group P: 120

excluded:

0

analysed:

group D: 120

group P: 120

follow-up:

26 hours

mode of anaesthesia

SpA: hyperbaric lidocaine 60–100 mg (adjusted for height)

surgical approach

not reported

postoperative pain management

group D:

diclofenac suppository 100 mg after surgery followed by 3 other identical doses at 8 h intervals

group P:

pethidine 1 mg/kg IM after surgery followed by other three doses at 8 h intervals

supplemental analgesia

pethidine 1 mg/kg as needed

 

 

postoperative pain [VAS]: mean ± SD

at 2 h

group D: 6.8 ± 2.3

group P: 7.3 ± 2.4

(p=NS)

at 10 h

group D: 2.05 ± 2.07

group P: 2.6 ± 2.2

(p<0.05)

at 18 h

group D: 1.4 ± 1.6

group P: 2.3 ± 2.2

(p<0.05)

at 26 h

group D: 0.5 ± 1.1

group P: 1.3 ± 1.9

(p<0.05)

satisfaction for pain relief

good: n (%)

group D: 85 (70.8)

group P: 73 (60)

(p=NS)

moderate: n (%)

group D: 31 (25.8)

group P: 36 (30)

(p=NS)

poor: n (%)

group D: 4 (3.3)

group P: 11 (9.2)

(p=NS)

adverse effects/ events

headache: n (%)

group D: 1 (0.8)

group P: 2 (1.6)

(p=NS)

dizziness: n (%)

group D: 0 (0)

group P: 11 (9.1)

(p<0.05)

PONV

similar between groups (not specified)

(p=NS)

methodological shortcomings

– allocation concealment not reported

– no blinding

– no sample size calculation

level of evidence: 2

authors’ conclusion

“Pethidine is one of the most effective opioids for pain relief after caesarean section, but general concerns have been raised for its wide side effects, high cost, and legal issues. It seems that diclofenac suppository is a suitable replacement for this drug because it has shown better analgesic effects on postoperative pain.”

 

reference participants’ characteristics intervention group/ control group

 

outcomes critical appraisal/ conclusion
Abboud 1991

Transnasal butorphanol: A new method for pain relief in post-cesarean section pain.

 

Acta Anaesthesiologica Scandinavica, 1991. 35(1): p. 14-18.

 

inclusion criteria

not reported

exclusion criteria

not reported

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean (range)

group 1: 26.9 (18–41)

group 2: 26.1 (16–40)

group 3: 26.1 (18–37)

group 4: 27.6 (18–43)

group 5: 26.2 (18–36)

baseline pain: moderate [%] / severe [%]

group 1: 41/ 59

group 2: 32/ 68

group 3: 42/ 58

group 4: 37/ 63

group 5: 41/ 59

patient flow and follow up:

total patient number included:

186

randomised in:

group 1: 37

group 2: 38

group 3: 36

group 4: 38

group 5: 37

excluded:

0

analysed:

all patients

follow-up:

72 hours

 

prior to anaesthesia

not reported

mode of anaesthesia

general anaesthesia (n=30)

– sodium thiamylat 4 mg/kg and succinylcholine

– 0.5% enflurane with 50% N2O and O2

spinal anaesthesia (n=98)

– usual manner with 1% tetracaine

epidural anaesthesia (n=58)

-2% lidocaine with 1:200 000 epinephrine

no spinal narcotics in regional anaesthesia group

surgical approach

not reported

postoperative pain management

group 1

2 mg intravenous butorphanol (IVB)

group 2

2 mg transnasal butorphanol (TNB)

group 3

1 mg TNB followed by a repeat dose of 1 mg TNB at 60 min

group 4

0.5 mg TNB followed by a repeat dose of 0.5 mg at 60 min

group 5

placebo

limited to a maximum of 12 doses/ day with maximum of 1 dose/ hour

rescue medication

morphine sulphate IM

duration of analgesia [h]: mean ± SEM

group 1: 3.05 ± 0.28a

group 2: 4.19 ± 0.28

group 3: 4.31 ± 0.29

group 4: 3.65 ± 0.27

group 5: 2.07 ± 0.28b

a p<0.05 vs. the other groups

b p<0.05 vs. group 2 or group 3

patient global assessment (pain intensity and pain relief): mean ± SEM

group 1: 3.19 ± 0.18

group 2: 3.20 ± 0.16

group 3: 3.00 ± 0.17

group 4: 2.65 ± 0.17

group 5: 2.04 ± 0.20b

b p<0.05 vs. group 2 or group 3

rescue medication

not reported

adverse effects/ events

no significant differences between the groups in:

– sensation of heat

– abnormal dreams

somnolence

significantly lower in group 5 (placebo) compared to group 1, 2 and 3

dizziness and sweating

significantly lower in group 5 (placebo) compared to group 1

methodological shortcomings

– generation of allocation sequence not reported

– allocation concealment not reported

– selective outcome reporting

– no sample size calculation

level of evidence: 1

authors’ conclusion

“Transnasal butorphanol represents a safe and effective alternative to injectable butorphanol for post-cesarean section pain and offers a better and longer duration of analgesia compared to IV butorphanol. The optimum dose seems to be 2 mg TN nutorphanol and it is tolerated better when divided into 1 mg increments, given 1 h apart.”

Davis 2006

Oral analgesia compared with intravenous patient-controlled analgesia for pain after cesarean delivery: A randomized controlled trial.

 

American Journal of Obstetrics and Gynecology, 2006. 194(4): p. 967-971.

 

inclusion criteria

– aged >/=18 yr.

exclusion criteria

– unplanned caesarean delivery

– known allergy/ hypersensitivity to morphine, oxycodone, or paracetamol

– treatment with magnesium sulphate

– chronic use of narcotics or substance abuse

– use of general anaesthesia

– history of a pain syndrome

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group O: 31.9 ± 4.5

group M: 31.5 ± 4.7

BMI [kg/m2]: mean ± SD

group O: 31.6 ± 5.1

group M: 32.6 ± 7.0

primiparous: n (%)

group O: 4 (9)

group M: 6 (13)

indication: group O: n (%)/ group M: n (%)

elective repeat: 34 (74)/ 34 (72)

malpresentation: 7 (15)/ 10 (21)

other: 5 (11)/ 3 (6)

patient flow and follow up:

total patient number included:

93

randomised in:

group O: 46

group M: 47

excluded:

0

analysed:

all patients

follow-up:

24 hours

mode of anaesthesia

SpA: bupivacaine and fentanyl (not specified)

surgical approach

Pfannenstiel incision (not specified)

after surgery

ketorolac 30 mg IV after surgery followed by 15 mg IV every 6 h for 24 h,

promethazine 25 mg IM every 4 h as needed for nausea

postoperative pain management

group O:

immediately after surgery:

2 tablets of oxycodone-paracetamol

for 12 h:

2 tablets of oxycodone-paracetamol at fixed intervals every 3 h

after 12 h:

1–2 tablets every 4 h as needed,

</=12 tablets in 24 h

group M:

immediately after surgery:

morphine via iPCA with continuous infusion of 1 mg/h, additional 1 mg dose was administered on demand (lockout 6 min)

after 12 h

iPCA discontinued, continued with oxycodone-paracetamol (5/325 mg) with 1–2 tablets every 4 h as needed

all patients after 24 h

oral oxycodone-paracetamol and ibuprofen (not specified)

rescue analgesia

meperidine 50 mg IM, as frequently as every 4 hours

postoperative pain [VAS]: mean ± SD

after 6 h

group O: 3.2 ± 1.8

group M: 4.1 ± 2.5

(p=0.04)

after 24 h

group O: 2.9 ± 1.7

group M: 4.1 ± 2.1

(0.004)

need for rescue analgesia: n

group O: 1

group M: 3

(p=0.71)

adverse effects/ events

nausea: mean ± SD

after 6 h

group O: 0.2 ± 0.9

group M: 2.0 ± 3.4

(p=0.001)

after 24 h

group O: 1.0 ± 2.0

group M: 0.3 ± 0.8

(p=0.04)

drowsiness: mean ± SD

after 6 h

group O: 2.9 ± 2.9

group M: 5.3 ± 3.3

(p<0.001)

after 24 h

group O: 2.4 ± 2.6

group M: 2.5 ± 2.6

(p=0.95)

pruritus: mean ± SD

after 6 h

group O: 0.9 ± 1.9

group M: 1.7 ± 2.5

(p=0.11)

after 24 h

group O: 1.0 ± 2.3

group M: 1.1 ± 1.8

(p=0.84)

emesis: n (%)

after 6 h

group O: 5 (11)

group M: 12 (26)

(p=0.11)

after 24 h

group O: 7 (15)

group M: 7 (15)

(p=1.00)

ambulation: n (%)

after 6 h

group O: 5 (11)

group M: 7 (15)

(p=0.76)

after 24 h

group O: 1 (2)

group M: 2 (4)

(p=1.00)

oral intake: n (%)

after 6 h

group O: 2 (4)

group M: 1 (2)

(p=0.62)

after 24 h

group O: 2 (4)

group M: 0 (0)

(p=0.24)

methodological shortcomings

– no blinding

level of evidence: 1

authors’ conclusion

“… oral analgesia with oxycodone-paracetamol for the treatment of post-caesarean pain appears to be a less expensive and more convenient option for providers and hospitals. It also offers superior pain relief with fewer undesirable side effects such as nausea and drowsiness for patients. Given this favourable profile, consideration should be given to expanding its use after planned caesarean delivery.“

Dieterich 2012

Pain management after cesarean: a randomized controlled trial of oxycodone versus intravenous piritramide.

 

Archives of gynecology and obstetrics, 2012. 286(4): p. 859-865.

 

 

inclusion criteria

– aged >18 years

– delivery of elective or secondary CS

– gestational age >36 weeks

– spinal anaesthesia

– no history of opioid or metamizol treatment

– ability to use PCA device

exclusion criteria

– CS in intubation anaesthesia

– use of epidural catheter for pre-, peri- or post-CS analgesia

– additional post-CS use of metamizol

– allergy/ hypersensitivity to morphine, oxycodone, paracetamol or ibuprofen

– chronic use of  opioids or history of chronic pain syndrome

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group O: 28.5 ± 5.9

group P: 29.8 ± 5.1

gestational age [wk.]: mean ± SD

group O: 39.2 ± 3.1

group P: 39.2 ± 2.7

indication: group O: n (%)/ group P: n (%)

maternal request: 12 (10.6)/ 11 (8.7)

medical indication: 47 (41.6)/ 61 (48.4)

secondary CS: 22 (19.5)/ 24(19.0)

previous CS: 28 (24.8)/ 30 (23.8)

previous other laparotomies: 4 (3.5)/ 0

closure vesical peritoneum: no closure n (%)/ closure n (%)

group O: 31 (27.4)/ 82 (72.6)

group P: 29 (23)/ 97 (77)

patient flow and follow up:

total patient number included:

239

randomised in:

group O: 113

group P: 126

excluded:

0

analysed:

all patients

follow-up:

72 hours

mode of anaesthesia

SpA: bupivacaine 10 mg and sufentanil 5 µg

surgical approach

Pfannenstiel incision (standard fashion)

-great importance not to exteriorize the uterus, as it might influence the visceral pain

postoperative pain management

treatment started 2 h after surgery

group O:

oral oxycodone 20 mg at 2 and 12 h after surgery

group P:

single use of piritramide 2 mg/mL IV in 0.9% saline via iPCA (bolus of 1 mg pritramide, lockout 5 min, </=30 mg piritramide) for 24 h

all patients for first day

oral ibuprofen 500 mg every 8 h

rescue analgesia

from first day ibuprofen 500 mg and paracetamol 1 g as needed

postoperative pain [VAS]:  mean ± SD

after 24 h

group O: 5.88 ± 2.01

group P: 4.85 ± 2.23

(p=0.34)

after 48 h

group O: 3.83 ± 1.34

group P: 3.85 ± 1.69

(p=0.72)

after 72 h

group O: 3.00 ± 1.84

group P: 2.65 ± 1.42

(p=0.86)

need for rescue analgesia: %

after 24 h

group O: 45

group P: 51

(p=0.57)

after 48 h

group O: 21

group P: 23

(p=0.057)

after 72 h

group O: 7

group P: 11

(p=0.30)

mobilisation [h]: mean ± SD

group O: 4.9 ± 1.3

group P: 5.2 ± 1.6

(p=0.24)

patient satisfaction on rating scale from 1 to 10:

group O: 8.75 ± 1.5

group P: 8.4 ± 2.1

(p=0.39)

clinical assessment of the newborn:
no difference in general health and  activity of the offspring

adverse effects/ events

“were minor and equally distributed between both groups and restricted to nausea, vomiting and headache” (not specified)

methodological shortcomings

– no blinding

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“…general satisfaction with both treatment regimes was a high. The results support the potential use of oral pain regimes and emphasis the importance of a multimodal approach to treat post-caesarean pain. Oral oxycodone is a not expensive, convenient and comparable analgesic to PCA devices with opioids after caesarean“

Safavi 2007

Postoperative analgesia after caesarean section: Intermittent intramuscular versus subcutaneous morphine boluses.

 

Acute Pain, 2007. 9(4): p. 215-219.

 

inclusion criteria

– ASA physical status I/II

– aged 16–45 yr.

exclusion criteria

– Mini Mental Status score <26

– emergency caesarean section

– contraindications to morphine use

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group SC: 24.2 ± 4.2

group IM: 25.9 ± 4.4

height [cm]: mean ± SD

group SC: 161.7 ± 6.1

group IM: 161.2 ± 4.1

weight [kg]: mean ± SD

group SC: 67.4 ± 9.4

group IM: 67.8 ± 11.3

ASA physical status I/ II

group SC: 26/ 4

group IM: 25/ 5

patient flow and follow up:

total patient number included:

60

randomised in:

group SC: 30

group IM: 30

excluded:

0

analysed:

all included patients analysed

follow-up:

48 hours

mode of anaesthesia

GA: induction with: thiopental 4 mg/kg followed by succinylcholine 1.5 mg/kg,

50% nitrous oxide in oxygen and 1.25% isoflurane,

after delivery: morphine 0.1 mg/kg,

muscle paralysis: atracurium

surgical approach

not reported

after delivery

boluses of morphine 0.15 mg/kg SC or IM every 10 min until VAS<30

postoperative pain management

group SC:

– butterfly needle was primed with morphine 10 mg/mL to fill needle dead space with 0.2 mL

– injection of 5 mg in 0.5 mL morphine

-subcutaneous injections of morphine (0.15 mg/kg) started 4h after the study or earlier if VAS >30, could be repeated every 4 h

group IM:

intramuscular injections of morphine (0.15 mg/kg), could be repeated every 4 h

 

postoperative pain [VAS]

at rest

no significant differences between the groups

on movement

significant lower pain scores in group SC at 12, 16 and 20 h, but not from 0 to 8 h and from 24 to 48 h

(p<0.05)

morphine consumption

no significant differences between the groups

recovery

hospital stay

no significant differences between the groups

adverse effects/ events: n (%)

no significant differences in

– nausea

– pruritus

methodological shortcomings

– allocation concealment not reported

– no blinding

-no sample size calculation

level of evidence: 1

authors’ conclusion

“…the subcutaneous route of morphine administration is a satisfactory alternative to IM morphine in management of postoperative pain after caesarean section surgery and warrants further investigation.”

Reference participants’s characteristics intervention group/ control group

 

outcomes critical appraisal/ conclusion
Alhashemi 2006

Intravenous acetaminophen vs oral ibuprofen in combination with morphine PCIA after Cesarean delivery

 

Canadian Journal of Anesthesia, 2006. 53(12): p. 1200-1206.

 

inclusion criteria

– >/=37 weeks pregnant

– caesarean section under spinal anaesthesia

exclusion criteria

– abnormally lying placenta

– prenatally diagnosed fetal abnormalities

– intra-uterine fetal death

– hypertensive diseases of pregnancy

– renal impairment

– any contraindication to spinal anaesthesia

– language barrier or mental disorder

– any allergy and/or contraindication to any of the study medications

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group A: 33 ± 5

group I: 32 ± 5

weight [kg]: mean ± SD

group A: 81 ± 16

group I: 78 ± 15

ASA status: [n I]/ [n II]

group A: 12/ 10

group I: 12/ 11

gestational age [weeks]: mean ± SD

group A: 38 ± 1

group I: 38 ± 1

parity

group A: 3 ± 2

group I: 3 ± 2

gravidity

group A: 4 ± 2

group I: 4 ± 2

patient flow and follow up:

total patient number included:

45

randomised in:

group A: 22

group I: 23

excluded:

0

analysed:

group A: 22

group I: 23

follow-up:

48 hours

 

mode of anaesthesia

– SpA using 2.5 mL of 0.5% hyperbaric bupivacaine mixed with fentanyl 10 µg

surgical approach

horizontal lower segment uterine incision

intraoperative pain

fentanyl 50 µg IV as needed

intra- and postoperative PONV

metoclopramide 10 mg IV every 6 h as needed

postoperative pain management

group A

– paracetamol 1 g (100 mL) IV over 15 min and one placebo tablet PO, each given every 6 h for 48 h

group I

– ibuprofen 400 mg PO and saline 100 mL IV over 15 min, each given every 6 h for 48 h

first administration in both groups 30 min before surgery

PACU

– morphine 0.05 mg/kg IV bolus

– iPCA: morphine bolus dose 2 mg IV, lockout 10 min, no basal infusion

rescue analgesia

– if VAS >/= 5:

morphine 5 mg IV bolus every 4 h as needed

– 48 h after surgery: tramadol 1 mg/kg IM every 4 hours

pain scores at rest

no significant differences

(p=0.143)

iPCA morphine consumption [mg]: mean ± SD

no significant differences

(p=0.562)

rescue morphine [n]

group A: 1

group I: 2

(p=1.0)

APGAR-Score

no significant differences between the groups

patient satisfaction with analgesia: mean ± SD

group A: 9 ± 1

group I: 9 ± 1

(p=0.93)

adverse effects/ events

no significant differences between the groups in:

– PONV

– respiratory depression

– oxygen desaturation

pruritus

group A: 10

group I: 19

(p=0.031)

 

methodological shortcomings

– no methodological shortcomings according to the evaluation sheet

level of evidence: 1

authors’ conclusion

“Intravenous paracetamol is a reasonable alternative to oral ibuprofen as an adjunct to morphine patient-controlled analgesia after cesarean delivery”

Omar 2011

Intravenous paracetamol (perfalgan) for analgesia after cesarean section: A double-blind randomized controlled study.

 

Rawal Medical Journal, 2011. 36(4).

inclusion criteria

– ASA physical status I–II

exclusion criteria

– known contraindication to paracetamol or meperidine

– history of severe allergic, hepatic, renal cardiovascular, pulmonary disease

– preeclampsia or eclampsia

– diabetes

– emergency caesarean section

– intraoperative complications, history of chronic abdominal pain or treated with analgesics

– conversion to general anaesthesia during surgery

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group P: 30.8 ± 4.79

group S: 29.6 ± 5.20

gestational age [days]: mean ±SD

group P: 269.86 ± 5.89

group S: 271.97 ± 6.59

repeat caesarean section: n (%)

group P: 32 (80)

group S: 29 (72.5)

nulliparity: n (%)/ multiparity: n (%)

group P: 8 (20)/ 32 (80)

group S: 11 (27.5)/ 29 (72.5)

patient flow and follow up:

total patient number included:

80

randomised in:

group P: 40

group S: 40

excluded:

0

analysed:

group P: 40

group S: 40

follow-up:

24 hours

mode of anaesthesia

– SpA: hyperbaric bupivacaine 8–10 mg mixed with morphine 0.2 mg

surgical approach

not reported

postoperative pain management

at the end of surgery

group P:

paracetamol IV (1 g/ 100 mL) at the end of surgery and every 6 h for 24 h

group S:

normal 100 mL saline at the stated time points

rescue analgesia

– meperidine (not specified)

pain scores: median (range)

at 6 h

group P: 1 (0–6)

group S: 4 (0–6)

(p<0.05)

at 12 h

group P: 2 (0–5)

group S: 3 (0–7)

(p<0.05)

at 24 h

group P: 1.5 (0–4)

group S: 3 (1–8)

(p<0.05)

rescue meperidine: n (%)

group P: 0 (0)

group S: 8 (20)

(p<0.05)

patient satisfaction with analgesia: mean ± SD

group P: 4.05 ± 0.59

group S: 4.33 ± 0.52

(p<0.05)

group P: 4.00 ± 0.50

group S: 4.25 ± 0.54

(p<0.05)

adverse effects/ events

not reported

 

methodological shortcomings

– selective outcome reporting

– no sample size calculation

level of evidence: 1

authors’ conclusion

“… intravenous paracetamol is an effective treatment option and can be used to reduce the requirement of rescue opioid drugs for pain control after caesarean section.”

Munishankar 2008

A double-blind randomised controlled trial of paracetamol, diclofenac or the combination for pain relief after caesarean section.

 

International Journal of Obstetric Anesthesia, 2008. 17(1): p. 9-14.

 

inclusion criteria

– =37 gestational weeks

– between 18 and 45 yr.

exclusion criteria

– any significant history of maternal medical or obstetric illness

– any evidence of fetal compromise within the current pregnancy

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group P: 31.9 ± 6.2

group D: 29.7 ± 6.4

group PD: 28.8 ± 5.8

maternal height [cm]: mean ± SD

group P: 160.5 ± 6.4

group D: 159.4 ± 6.6

group PD: 163.2 ± 6.0

maternal weight [kg]: mean ± SD

group P: 73.0 ± 13.1

group D: 73.3 ± 13.3

group PD: 76.0 ± 14.3

gestation (wk.): mean ± SD

group P: 39.0 ± 0.8

group D: 38.7 ± 0.5

group PD:39.1 ± 0.9

patient flow and follow up:

total patient number included:

78

randomised in:

group P: 26

group D: 26

group PD: 26

excluded: 4

group P:

request for rescue analgesia:2

group D:

due to excessive vomiting:1

group PD:

due to excessive vomiting:1

analysed: 74

group P: 23

group D: 25

group PD: 26

follow-up:

24 hours

mode of anaesthesia

infusion of Ringers Lactate IV

SpA: bupivacaine 5 mg/mL with dextrose 80 mg/mL in 2.25–2.5 mL, mixed with fentanyl 12.5 µg (total volume 2.5–2.75 mL)

– if systolic blood pressure <100 mmHG increments of IV ephedrine 3–6 mg

surgical approach

not reported

postoperative pain management

suppositories given at the end of surgery

group P:

paracetamol 1 g

group D:

diclofenac 100 mg

group PD:

paracetamol 1 g and diclofenac 100 mg

6 h after surgery

group P:

oral paracetamol 1 g 6-hourly and placebo 8-hourly

group D:

placebo 6-hourly and oral diclofenac 50 mg 8-hourly

group PD:

oral paracetamol 1 g 6-hourly and and oral diclofenac 50 mg 8-hourly

 

supplemental analgesia

morphine via iPCA (bolus 1 mg, lockout 5 min.)

rescue analgesia:

morphine IV (not specified)

 

postoperative pain [VAS]:

at rest and on movement

no significant differences between the groups

morphine consumption via iPCA

in consecutive 4 h periods up to 24 h

PD < P, differences were significant between all time periods except 8–11.9 h and 12–15.9 h.

consumption after 24 h: mean ± SD

group P: 54.5 ± 28.5*

group D: 44.1 ± 24.4

group PD:33.8 ± 23.8*

(p=0.02, difference between groups)

iPCA attempts: mean ± SD

group P: 68.7 ± 35.6*

group D: 63.7 ± 31.8

group PD: 40.3 ± 30.3*

(p=0.04, difference between groups))

satisfaction score

significantly higher in group D and group PD compared with group P

(p<0.001)

recovery

time to first independent mobilisation (h): mean ± SD

group P: 22.8 ± 2.8

group D: 24.6 ± 14.4

group PD:19.4 ± 6.7

(p=0.39)

adverse effects/ events

no significant differences in:

– heart rate

– systolic and diastolic blood pressure

methodological shortcomings

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“…patients given a combination of paracetamol and diclofenac for pain relief after caesarean section use significantly less morphine compared to patients given paracetamol alone. Almost one third of patients in the paracetamol group were dissatisfied with pain management after surgery. Larger studies are required to investigate the differences between diclofenac alone and the combination of paracetamol and diclofenac, particularly when long-acting intrathecal opioids are used.”

Reference participants‘ characteristics intervention group/ control group

 

Outcomes critical appraisal/ conclusion
Bamigboye 2009

Local anaesthetic wound infiltration and abdominal nerves block during caesarean section for postoperative pain relief.

 

Cochrane Database Syst Rev, 2009(3): p. Cd006954.

databases/ search engines

– Cochrane Pregnancy  and Childbirth Group’s Trials Register

– Central

– Pubmed/ Medline

– hand searches of 30 journals

search period

through 04.2009

inclusion criteria

– randomised controlled trials

– comparing pre-emptive local analgesia:

1) local anaesthetic agent wound infiltration versus placebo/ no infiltration

2) ilioinguinal/ iliohypogastric  nerve block versus placebo/ no treatment

3) local anaesthetic agent vs other methods of pain relief

4) comparison of different local anaesthetic agent techniques

included studies (n participants)

[1] Bamigboye 2008 (100)

[2] Bell 2002 (59)

[3] Caulry 2003 (10)

[4] Chen 1990 (36)

[5] Ganta 1994 (62)

[6] Givens 2002 (36)

[7] Kumar 1999 (50)

[8] Kuppuvelamini 1992 (60)

[9] Lacrosse 2004 (55)

[10] Lavand’homme 2007 (90)

[11] Marbaix 2004 (55)

[12] McDonnell 2008 (50)

[13] Mecklem 1995 (79)

[14] Pavy 1994 (40)

[15] Pirbudak 2004 (60)

[16] Rosaeg 1997 (40)

[17] Solak 1999 (30)

[18] Trotter 1991 (28)

[19] Zohar 2002 (50)

[20] Zohar 2006 (90)

[1] Bamigboye 2008

IG: 225 mg ropivacaine if >/=64 kg and 3 mg/kg if less,

CG: equivalent volume of saline,

all layers of the anterior abdominal incision infiltrated including the peritoneum,

postoperatively: pethidine, diclofenac injection and oral paracetamol/tramadol

[2] Bell 2002

IG: ilioinguinal-iliohypogastric nerve block with 0.5% bupivacaine with adrenaline,

CG: saline placebo

[3] Caulry 2003

IG1: ropivacaine

IG2: diclofenac

CG: saline

wound irrigation in each group

[4] Chen 1990

IG1: plain marcaine

IG2: marcaine with adrenaline

CG: no treatment

ilioinguinal nerve block after caesarean section

[5] Ganta 1994

IG: bilateral ilioinguinal nerve block with 0.5% bupivacaine

CG1: wound infiltration with 0.5% bupivacaine,

CG2: no local anaesthetic

[6] Givens 2002

IG: wound irrigation with 0.25% bupivacaine,

CG: normal saline solution irrigation

[7] Kumar 1999

IG: pre-incisional 40 mL of 0.5% bupivacaine,

CG: 40 mL of bupivacaine and 2 mg morphine mixture

[8] Kuppuvelamini 1992

IG: mixture of 0.5% bupivacaine with adrenaline with 1% xylocaine injected to block the ilioinguinal/iliohypogastric,

CG: no abdominal nerve block

[9] Lacrosse 2004 (55)

IG1: wound irrigation with 300 mg of diclofenac for 48 h,

IG2: ropivacaine 0.2%,

CG: saline control

[10] Lavand’homme 2007

continuous wound infiltration of:

IG1: diclofenac,

IG2: 0.2% ropivacaine

CG: saline

[11] Marbaix 2004

IG: wound irrigation with 300 mg of diclofenac for 48 h,

CG1: ropivacaine 0.2%,

CG2: saline

[12] McDonnell 2008

IG: 1.5 mg/kg ropivacaine, per side injection into the transversus abdominis plane

CG: saline TAP block

[13] Mecklem 1995

IG: 0.25% bupivacaine

CG: saline

[14] Pavy 1994

IG: 0.5% bupivacaine,

CG: saline

[15] Pirbudak 2004

IG: 40 mL of 0.25% bupivacaine + 100 mg tramadol + 20 mg tenoxicam,

CG: normal saline

[16] Rosaeg 1997

both groups received 0.75% bupivacaine spinal analgesia:

IG: IT morphine, incisional bupivacaine and ibuprofen and acetaminophen,

CG: IV morphine weaned to acetaminophen and codeine

[17] Solak 1999

IG: 20 mL of 0.5% bupivacaine,

CG: saline

[18] Trotter 1991

IG: 0.5% bupivacaine,

CG: saline

[19] Zohar 2002

multi-holed device placed in wound and connected to a PCA:

IG: bupivacaine,

CG: combined with ketamine

[20] Zohar 2006

IG1: wound instillation via a patient-controlled analgesic infusion pump of 0.25% bupivacaine and 75 mg intravenous diclofenac.

CG1: only bupivacaine instillation,

CG2: only diclofenac infusion

wound infiltration with local anaesthetic only versus control

wound infiltration associated with:

reduced morphine consumption at 24 h: SMD (95% CI)

-1.70 mg (-2.75;-0.94) [3,6,13]

no difference in pain scores at 24 h: MD (95% CI)

-0.39 (-1.72;0.94) [3,6]

wound infiltration with local anaesthetic and peritoneal spraying versus placebo

local anaesthetic and peritoneal spraying associated with:

reduced need for pethidine rescue within 1 h: risk ratio (95%)

0.51 (0.38;0.69) [1]

reduced pain scores at 1 h: MD (95% CI)

-1.46 (-2.60;-0.32) [1]

similar pain scores at 8 h: MD (95% CI)

-0.58 (-3.29;2.13) [1]

similar pain scores at 24 h: MD (95% CI)

0.19 (-0.67;1.05) [1]

similar consumption of total pethidine at 24 h: MD (95% CI)

-44.0 (-108.31;20.31) [1]

reduced consumption of oral paracetamol/tramadol: MD (95% CI)

-2.35 (-3.62;-1.08) [1]

wound infiltration with local anaesthetic + nonsteroidal anti-inflammatory drugs versus control

associated with:

similar no of attempts to activate PCA: MD (95% CI)

-15.0 (-30.22;0.22) [20]

reduced total morphine [mg] used in the first 18 h: MD (95% CI)

-7.4 (-9.58;-5.22) [20]

similar occurrence of nausea: risk ratio (95% CI)

1.40 (0.9;2.16) [16]

increased occurrence of pruritus: risk ratio (95% CI)

1.81 (1.01;3.23) [16]

abdominal nerve blocks with local anaesthetic versus placebo block or no block

associated with:

lower pain scores [VAS] at 24 h: MD (95% CI)

-1.82 (-2.74;-0.9) [2,4]

reduced postoperative opioid use [mg]: MD (95% CI)

-25.80 (-50.39;-1.21) [2,4,5,12]

wound infiltration with local anaesthetic versus local anaesthetic + narcotics

associated with:

similar pain scores at 2 h: MD (95% CI)

0.69 (-0.08;1.46) [7]

similar pain scores at 12 h: MD (95% CI)

0.18 (-0.59;0.95) [7]

similar pain scores at 24 h: MD (95% CI)

-0.15 (-0.92;2.94) [7]

wound infiltration with local anaesthetic versus local anaesthetic + ketamine

associated with:

similar total morphine consumption </=6 h: MD (95% CI)

0.10 (-2.74;2.94) [19]

 

methodological shortcomings

– publication bias not assessed

level of evidence: 1

authors’ conclusion

“Local analgesia infiltration and abdominal nerve blocks as adjuncts to regional analgesia and general anesthesia are of benefit in caesarean section by reducing opioid consumption. Nonsteroidal anti-inflammatory drugs as an adjuvant may confer additional pain relief.”

Wolfson 2012

Bilateral multi-injection iliohypogastric-ilioinguinal nerve block in conjunction with neuraxial morphine is superior to neuraxial morphine alone for postcesarean analgesia.

 

Journal of Clinical Anesthesia, 2012. 24(4): p. 298-303.

 

 

inclusion criteria

– not reported

exclusion criteria

– preeclampsia

– eclampsia

– history of substance abuse

– peptic ulcer disease

– renal disease

– progressive neurologic disease

– allergies to local anaesthetics, NSAIDs, or opioids

– infection at the site of block

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group IG: 28 ± 6

group CG: 25 ± 7

height [cm]: mean ± SD

group IG: 165 ± 9

group CG: 163 ± 5

weight [kg]: mean ± SD

group IG: 88 ± 24

group CG: 91 ± 12

BMI: mean ± SD

group IG: 32 ± 7

group CG: 34.3 ± 5

gestational age [wk.]: mean ± SD

group IG: 39 ± 1

group CG: 39 ± 1

patient flow and follow up:

total patient number included:

50

randomised in:

group IG: 25

group CG: 25

excluded: 16

8 in each group due to receiving epidural block instead of SpA

analysed: 34

group IG: 17

group CG: 17

follow-up:

24 hours

mode of anaesthesia

SpA: 0.75% bupivacaine 12 mg with fentanyl 10 µg and preservative-free morphine 200 µg

surgical approach

low transverse caesarean section via Pfannenstiel incision

iliohypogastric-ilioinguinal (IHII) peripheral nerve block

needle was inserted at a point 2 cm medial and 2 cm superior to the anterior superior iliac spine

IG:

– 0.5% bupivacaine 2 mL injected between external and internal oblique muscle layers,

– another 2 mL of anaesthetic solution were injected between the internal oblique and transversus abdominus muscles,

– laterally at 15°-angles two injections

– same six injection procedure was repeated on the contralateral side,

– in total, 24 mL of anaesthetic solution were deposited (6 injections per side).

CG:

placebo (saline)

postoperative pain management

ketorolac 30 mg IV at first request for pain relief

supplemental analgesia

paracetamol  500 mg/ oxycodone 5 mg tablets every 6 h on request

rescue analgesia

intravenous morphine via PCA (2 mg, lockout 10 min)

pain scores [VAS]: median (IQR)

                                group IG                group CG

in PACU                  0 (0–0)                   0 (0–0)

at 6 h                      0 (0–10)                 30 (10–60)*

at 12 h                    10 (0–15)              20 (15–45)*

at 18 h                    10 (10–20)            30 (10–40)*

at 24 h                    15 (10–30)            40 (10–50)*

*p<0.05

time to first request for analgesia [h]: mean ± SD

group IG: 14.3 ± 1.8

group CG: 5.6 ± 1.1

(p<0.01)

request for supplemental analgesia (acetaminophen and oxycodone): n (%)

group IG: 1 (6)

group CG: 12 (71%)

(p<0.01)

need for rescue analgesia (PCA morphine)

no patients in either group

maternal satisfaction with pain relief regimen: median (IQR)

a significant greater degree at 6, 12 and 18 h, but not in PACU and 24 h

                                group IG                group CG

in PACU                  5 (5–5)                   5 (5–5)

at 6 h                      5 (5–5)                   4 (4–5)*

at 12 h                    5 (5–5)                   4 (4–5)*

at 18 h                    5 (5–5)                   5 (4–5)*

at 24 h                    5 (5–5)                   5 (4–5)

*p<0.05

adverse effects/ events

no significant differences in PONV and pruritus

nausea (n)            group IG                  group CG

in PACU                  2                              5

at 6 h                      3                              3

at 12 h                    2                              0

at 18 h                    0                              1

at 24 h                    0                              0

vomiting (n)          group IG                  group CG

in PACU                  1                              2

at 6 h                      1                              0

at 12 h                    0                              0

at 18 h                    0                              0

at 24 h                    0                              0

pruritus (n)           group IG                  group CG

in PACU                 2                              7

at 6 h                      6                              10

at 12 h                    6                              6

at 18 h                    3                              4

at 24 h                    2                              2

methodological shortcomings

no methodological shortcomings according to the evaluation sheet

level of evidence: 1

authors’ conclusion

“… the use of bilateral IHII multi-injection nerve blocks, given in conjunction with neuraxial morphine, is an effective way to optimise analgesia for the first 24 hours after caesarean delivery”

Sakalli 2010
The efficacy of ilioinguinal and iliohypogastric nerve block for postoperative pain after caesarean sectionJournal of Research in Medical Sciences (2010), Vol 15 (1): p. 6-13
inclusion criteria

– ASA physical status I/II

– term parturients scheduled for caesarean section under GA

exclusion criteria

– preeclampsia

– eclampsia

– renal, hepatic or cardiac disorders

– history of allergy to the study drugs

– history of chronic pain and chronic analgesia use

– any infection on the nerve block area

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group II-IH: 26.27 ± 2.72

group P: 27.13 ± 4.20

weight [kg]: mean ± SD

group II-IH: 72.93 ± 8.12

group P: 77.30 ± 10.20

height [cm]: mean ± SD

group II-IH: 163.80 ± 4.96

group P: 164.03 ± 4.56

total patient number included:

64

randomised in:

group II-IH: 32

group P: 32

excluded: 4

group II-IH:

– because of blood aspiration with a negative aspiration test at the nerve block area while performing the II-IH block
(n=2)

group P:

– because of blood aspiration with a negative aspiration test at the nerve block area while performing the II-IH block
(n=2)

analysed:

group II-IH: 30

group P: 30

follow-up:
24 hours

prior to anaesthesia

– 150 mg ranitidine or 20 mg famotidine PO the night before surgery

– 30 mL sodium citrate 0.3 mol/L PO 30 min before induction of anaesthesia

general anaesthesia:

– 5 min preoxygenation

– induction was performed with thiopental 4 mg/kg and 1 mg/kg rocuronium IV
– ventilation with desflurane 3% and nitrous oxide 50% in oxygen

intraoperative analgesia

– 1 µg/kg fentanyl IV after cord clamping

postoperative pain management

after antagonization of the neuromuscular block with neostigmine 0.04 mg/kg IV and 0.02 mg/kg atropine (before extubation) blocks were performed:

Group II-IH:

nerve block: 0.5% ropivacaine 10 mL on each side (total volume 20 mL)

Group P:
– sham block with saline

supplemental analgesia

all patients received IV tramadol (50 mg loading dose, bolus 25 mg and lock out time 15 min, 4 h >/= 300 mg) via PCA

rescue analgesia 
IV meperidine 0.5 mg/kg

pain scores (VAS)
at rest
significantly lower in group II-IH at 6, 8, 12, and 24hp<0.05with movementsignificantly lower in group II-IH at 6 and 8hp<0.05tramadol consumption [mg] mean ± SD
group II-IH: 331 ± 82group P: 622 ± 107(p<0.05)rescue analgesia: n
group II-IH: 7group P: 1(p= NS)blood pressure and heart rateno differences between groupsadverse events/ effects
no differences between groups with regard to- nausea- vomiting

– sedation

(p=NS)

 

methodological shortcomings

– generation of sequence generation not reported

– blinding of outcome assessor not reported

level of evidence: 1

authors’ conclusion

“… II-IH nerve block, performed after CS operations under general anesthesia, increased the quality of pain control in the postoperative period and apparently decreased the consumption of tramadol. Therefore it is advocated that II-IH nerve block, performed after the operation, is a preferable technique for the pain control after CS.“

Bunting 1988
Ilioinguinal nerve blockade for analgesia after caesarean sectionBritish Journal of Anaesthesiology 1988, 61: p. 773-775 
inclusion criteria

– wish to have GA

exclusion criteria

– not reported

demographic data:

no significant differences in baseline characteristics

(data not shown)

total patient number included:

26

randomised in:

group B: 13

group P: 13

excluded:

not reported

follow-up:
24 hours

 

prior to anaesthesia

– 150 mg ranitidine PO 2 doses in 12 h before surgery

– 30 mL sodium citrate 0.3 mol/L PO before induction of anaesthesia

general anaesthesia:

– preoxygenation for 4 min

– induction with thiopentone 4 mg/kg and suxamethonium 1.5 mg/kg

– neuromuscular blockade maintained with vecuronium 0.1 mg/kg
– anaesthesia maintained using nitrous oxide and enflurane in oxygen

at delivery

all received oxytocin 10 unit followed by fentanyl 100 µg
at the end of surgery:
group B:

block was performed (technique not described) with 0.5% bupivacaine (10 mL)

group P:
no nerve block

postoperative pain management:

– papaveretum 10 mg/m² body surface area

pain scores (VAS)

significantly lower pain scores in group B than in group P at 0, 4, 8 and 24 h, but not at 12 h
p<0.01

consumption of papaveretum at 24 h [mg/m2]: mean (range)
group B: 16.57 mg/m² (0–47.05)
group P:  51.5  mg/m² (27–76.9)

(p<0.01)

adverse events/ effects

not reported

methodological shortcomings

– allocation concealment not reported

– generation of sequence unclear

– blinding of patients unclear

– no sample size calculation

– selective outcome reporting

– incomplete outcome data

level of evidence: 2

authors’ conclusion

“… when general anaesthesia is indicated for lower segment Caesarean section using a Pfannenstiel incision, bilateral ilioinguinal nerve blocks improve the quality of postoperative analgesia.“

Vallejo 2012

Efficacy of the bilateral ilioinguinal-iliohypogastric block with intrathecal morphine for postoperative caesarean delivery analgesia

 

The scientific world journal 2012, p: 1-6

inclusion criteria

– ASA physical status I/II

– singleton fetus >37 weeks

– SpA

exclusion criteria
– emergent caesarean delivery for maternal or fetal distress

– preeclampsia

– eclampsia

– history of substance abuse

– progressive neurological disease

– infection at insertion site

– allergy to local anaesthetics and narcotics

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group A: 31.35 ± 4.74

group B: 30.88 ± 5.34

group C: 31.76 ± 5.52

weight [kg]: mean ± SD

group A: 85.73 ± 20.02

group B: 87.53 ± 17.92

group C: 89.65 ± 25.37

height [cm]: mean ± SD

group A: 163.36  ± 8.51

group B: 160.97 ± 7.20

group C: 162.40 ± 8.10

gravity  median (range)
group A: 2 (1–6)

group B: 2 (1–5)

group C: 3 (1–5)

parity  median (range)
group A: 1 (0–3)

group B: 1 (0–3)

group C: 1 (0–4)

total patient number included:

51

(1 excluded to logistical problems)

randomised in:

group A: 17

group B: 16

group C: 17

excluded:

0

analysed:

group A: 17

group B: 16

group C: 17

follow-up:
48 hours

SpA
0.75% hyperbaric bupivacaine (12 mg) plus morphine (0.15–0.2 mg) and fentanyl (10–20 µg)surgical approach:
low transverse incision(not specified)postoperative pain management
Group A:IIIH block with 10 mL of 0.5% bupivacaine bilateral under ultra-sound guidance
Group B:IIIH block with 10 mL of 0.5% bupivacaine on one side on the other side normal saline under ultra-sound guidance
Group C:IIIH block with 10 mL normal saline bilateral under ultra-sound guidancesupplemental analgesiafollowing protocol:- IV ketorolac 30 mg every 6 h for POD 1
– followed by ibuprofen, oxycodone, paracetamol/oxycodone and paracetamol/ hydrocodone PO per patients preferences(in study opioids were converted to IV morphine dosage to yield total morphine equivalents)
median pain score
no significant differences between the groups for 48 hpostoperative analgesic requirements over 48 hno significant differences between the groupsadverse effects/ events
no significant differences between the groups in:- nausea- pruritus- emesispatient satisfactionno significant differences between the groupsrecoveryno significant differences in ambulation time
methodological shortcomings

– allocation concealment not reported

– blinding of outcome assessor not reported

level of evidence: 1

authors’ conclusion

“… the IIIH block under ultrasound guidance does not improve postoperative analgesia or decrease opioid side effects such as nausea, vomiting, and pruritus in patients receiving spinal anesthesia with ITM for Caesarean delivery.”

Reference participants‘ characteristics intervention group/ control group

 

outcomes critical appraisal/ conclusion
Fusco 2014

Transversus abdominis plane block for analgesia after Cesarean Delivery. A systematic review.

 

Minerva Anestesiologica 2014 Apr 16 [EPUB ahead of print]

 

databases/ search engines

– Medline

– Cochrane Database of Systematic Reviews

– Cochrane Controlled Clinical Trial Register

– Embase

– Scopus

– ISI Web of Knowledge

search period

through 31.12.2013

inclusion criteria

– randomised controlled trials

– studies comparing TAP block with placebo in patients undergoing SpA

– all publication years and all languages

exclusion criteria

– studies not reporting data

– pathological obesity

– taking medications known to result in tolerance to opioids

– chronic pain

– duplicate or ancillary studies

– primary outcome of interest not analysed

included studies (n participants)

[1] McDonnell 2008 (50)

[2] Belavy 2009 (47)

[3] Costello 2009 (96)

[4] Kanazi 2010 (57)

[5] Baaj 2010 (40)

[6] McMorrow 2011 (80)

[7] Loane 2012 (66)

[8] Bollag 2012 (90)

[9] Canovas 2013 (90)

[10] Singh 2013 (60)

[11] Lee 2013 (51)

 

TAP block technique and anaesthetic solution

[1] landmark technique:

ropivacaine 0.75% (1.5 mg/kg) to </=150 mg per side

[2] US-guided:

ropivacaine 0.5% 100 mg per side

[3] US-guided:

ropivacaine 0.375% 75 mg per side

[4] US-guided:

bupivacaine 0.375% + epinephrine 5 mg/mL 75 mg per side

[5] US-guided:

bupivacaine 0.25% 50 mg per side

[6] Landmark technique:

bupivacaine 0.375% 1 mg/kg per side

[7] US-guided:

ropivacaine 0.5% 100 mg per side

[8] US-guided:

bupivacaine 0.375% and bupivacaine 0.375% + 75 µg clonidine per side

[9] US-guided:

levobupivacaine 0.5% per side

[10] US-guided:

ropivacaine 0.5% 3 mg/kg to </=300 mg in TAP high and ropivacaine 0.25% 1.5 mg/kg to </=150 mg TAP low

[11] US-guided:
ropivacaine 0.5% 100 mg per side

opioids in surgical analgesia

[1] 25 µg IT fentanyl

[2] 15 µg IT fentanyl

[3] 10 µg IT fentanyl;

100 µg IT morphine

[4] 200 µg IT morphine

[5] 20 µg IT fentanyl

[6] 10 µg IT fentanyl;

100 µg IT morphine

[7] 10 µg IT fentanyl;

100 µg IT morphine

[8] 25 µg IT fentanyl and 100 µg IT morphine

[9] 100 µg IT morphine 10 µg IT fentanyl

[10] 10 µg IT fentanyl and 150 µg IT morphine

[11] 250 µg IT morphine and 15 µg IT fentanyl

postoperative analgesia

[1] 1 g/6 h of paracetamol, rectal diclofenac 100 mg/18 h and PCA with morphine

[2] 1 g/6 h of paracetamol, ibuprofen 400 mg/8 h and PCA with morphine

[3] 1 g/6 h of paracetamol, oral diclofenac 50 mg/8 h and morphine

[4] rectal diclofenac 100 mg/12 h paracetamol 1 g/6 h, tramadol 100 mg/8 h

[5] PCA with morphine

[6] oral paracetamol 1g/h; rectal diclofenac 100 mg/18 h and morphine with PCA

[7] oral paracetamol 1 g/6 h, oral or rectal naproxen 500 mg/12 h and oral hydromorphone 2–4 mg/4 h; morphine with PCA if pain control is inadequate

[8] paracetamol 1 g/6 h, diclofenac 75 mg/8 h and oral tramadol 50 mg/8 h

[9] morphine with PCA

[10] ketorolac 30 mg oral, paracetamol 650 mg/6 h, codeine 30 mg or oxycodone 5–10 mg/4 h

[11] paracetamol 1g/6 h, ketorolac 30 mg or ibuprofen 800 mg/6 h, IV morphine 2 mg/10 min as needed, paracetamol 300 mg/codeine 30 mg 2 times/6 h or oxycodone 5 mg/paracetamol 325 mg 2 times/6 h

time to first analgesic request

analysed in seven trials [1,2,4,8-11]

– shorter in placebo group vs TAP block group in women who received IT opioids [1,2,8,9,11]

– longer with IT morphine group only than in TAP block group only [4]

– no difference between IT morphine group and TAP block group at 24 h in patients who received IT opioids [10]

postoperative analgesic consumption

opioid consumption analysed in four trials [1,2,6,7]

– significant reduction of opioids at 48 h [1]

– reduction of opioids at 24 h in TAP block group vs placebo group in patients who received IT opioids [2,5]

– greater supplemental morphine requirements compared with IT morphine alone [7]

postoperative pain

analysed in all trials

– TAP block vs IT opioids did not improve pain relief [4,6,7]

– TAP block added to IT opioids did not improve pain relief [3,8,9]

– TAP block added to IT opioids, comparison with placebo, reduced pain intensity [1,2,5,11]

 

adverse effects/ events

analysed in 10 trials [1,2,4-11]

PONV and sedation

TAP block reduced PONV but without significant difference for sedation [1,2,4-11]

 

pruritus

– reduced in four trials [4,6,7,9]

– no difference in three trials [2,8,10]

 

all opioid-related side effects

analysed in 3 trials [8,10,11]

no difference in patients in occurrence or severity of PONV, sedation and pruritus

 

patient satisfaction

analysed in 7 trials [2,3,5,6,9-11]

– high satisfaction with TAP block added to intrathecal opioids compared with placebo group [2,5,9]

– similar between the groups [3,6,10,11]

methodological shortcomings (AMSTAR):

– can`t answer if a priori design was provided

– excluded/ included list is not provided

– no conflicts of interests stated

 

level of evidence: 1

 

authors’ conclusion

“If correctly executed, US-guided TAP block as a part of multimodal analgesic regimen including intrathecal opioids might reduce postoperative opioids consumption and opioid-related side effects, improving postoperative pain control and patient satisfaction, but further studies are necessary to explore this field of research…“

Tan 2012

A randomised trial of the analgesic efficacy of ultrasound-guided transversus abdominis plane block after caesarean delivery under general anaesthesia.

 

Eur J Anaesthesiol, 2012. 29(2): p. 88-94.

inclusion criteria

– ASA physical status I/II

– aged >/=18 yr.

– elective or grade 3 emergency caesarean delivery

– general anaesthesia

exclusion criteria

– chronic pain states

– history of postoperative nausea and vomiting

– known allergies or contraindication to any of drugs used in study

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group TAP: 31.9 ± 2.0

group noTAP: 29.2 ± 1.7

maternal BMI [kg/m2]: mean ± SD

group TAP: 27.7 ± 0.7

group noTAP: 29.6 ± 1.5

patient flow and follow up:

total patient number included:

40

randomised in:

group ED: 20

group SM: 20

excluded:

0

analysed:

all randomised patients analysed

follow-up:

24 hours

mode of anaesthesia

GA: induced with thiopentone 5 mg/kg,

maintained with sevoflurane at end-tidal concentration of 2.5%

surgical approach

not reported

intraoperative pain management

IV morphine 0.15 mg/kg

after delivery and cord clamping:
slow administration of  oxytocin 5 lU

additional drugs

dexamethasone 4 mg and ondansetron 4 mg

at the end of surgery

neostigmine 2.5 mg and atropine 0.9 mg to antagonise residual neuromuscular blockade

group TAP:

US-guided bilateral TAP block:

20 mL of levobupivacaine 2.5 mg/mL with aspiration after every 5 mL

group noTAP:

no TAP Block or skin punctured

surgical bandage/ dressing to maintain blinding

postoperative pain management

IV morphine via PCA

(bolus dose 1 mg lockout 5 min, </=40 mg/4 h)

intraoperative morphine [mg]: mean ± SD

group TAP: 10.7 ± 0.4

group noTAP: 10.6 ± 0.4

postoperative morphine consumption at 24 h [mg]: mean ± SD

group TAP: 12.3 ± 2.6

group noTAP: 31.4 ± 3.1

(p<0.001)

postoperative pain at rest and on activity [VAS]

no differences between the two groups

adverse effects/ events

PONV

no differences between the two groups

sedation

no differences between the two groups

patient satisfaction: n (%)

very satisfied

group TAP: 16 (80)

group noTAP: 5 (25)

(p=0.012)

methodological shortcomings

– no methodological shortcomings according to the evaluation sheet

level of evidence: 1

authors’ conclusion

“… US-guided TAP blocks in the manner we have described resulted in reduced systemic morphine consumption and positive impact on maternal satisfaction in women undergoing caesarean section under general anaesthesia. We propose that the TAP block is another arsenal in the obstetric anaesthesiogist’s armamentarium in managing pain after caesarean section and is a valuable resource in patients undergoing general anaesthesia, or in those with contraindications to long-acting neuraxial opioids.”

Eslamian 2012

Transversus abdominis plane block reduces postoperative pain intensity and analgesic consumption in elective cesarean delivery under general anesthesia.

 

J Anesth, 2012. 26(3): p. 334-8.

inclusion criteria

– ASA physical status I/II

– primiparous singleton pregnant women

– aged 20–40 yr.

– elective caesarean delivery

– general anaesthesia

exclusion criteria

– history of addiction (including opioids and benzodiazepines)

– sensitivity to prescribed analgesics

– psychological disorders

– coagulopathy

– any patients with surgical complications during surgery

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group TAP: 27.88 ± 3.9

group noTAP: 25.54 ± 3.8

maternal weight [kg]: mean ± SD

group TAP: 68.8 ± 3.0

group noTAP: 69.9 ± 4.2

maternal height [cm]: mean ± SD

group TAP: 162.1 ± 3.37

group noTAP: 162.8 ± 3.34

ASA physical status I/II

group TAP: 14/10

group noTAP: 15/9

patient flow and follow up:

total patient number included:

50

randomised in:

group TAP: 25

group noTAP: 25

excluded: 2

one in each group due to surgical complications

analysed:

group TAP: 25

group noTAP: 25

follow-up:

24 hours

mode of anaesthesia

GA: induced with sufentanil 5 µg and thiopental sodium 5 mg/kg,

maintained with isoflurane 0.8%, N20 50% and 0.4 mg/kg artracurium

surgical approach

Pfannenstiel incision

after delivery

morphine 0.1 mg/kg and

sufentanil 15 µg

at the end of surgery

group TAP:

US-guided bilateral TAP block

(0.25% bupivacaine 15 mL in each side)

group noTAP:

no TAP Block

surgical bandage/ dressing to maintain blinding

postoperative pain management

supplemental analgesia

diclofenac suppository 100 mg daily

 

rescue analgesia

IV tramadol 50 mg/4 h

postoperative pain

at rest [VAS]: median (range)

group TAP        group noTAP

0h         0 (0–2)              4 (0–8)

6h         1 (0–4)              6 (3–9)

12h       1 (0–3)              3 (1–5)

24h       0 (0–1)              0 (0–3)

(p<0.001)

during coughing [VAS]: median (range)

group TAP        group noTAP

0h         0 (0–2)              4 (0–8)

6h         1 (0–4)              6 (3–9)

12h       1 (0–3)              3 (1–5)

24h       0 (0–1)              0 (0–3)

(p<0.001)

time to first analgesic request [min]

group TAP: 210 (0–300)

group noTAP: 30 (10–180)

(p<0.001)

postoperative tramadol consumption [mg]

group TAP: 75 (0–150)

group noTAP: 250 (0–400)

(p<0.001)

 

 

methodological shortcomings

– allocation concealment unclear

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“Two-sided TAP block with 0.25% bupivacaine in parturients who undergo cesarean section with a Pfannenstiel incision under general anesthesia can decrease postoperative pain and analgesic consumption. The time to the first analgesic rescue was longer in the parturients who received the TAP block.”

McMorrow 2011

Comparison of transversus abdominis plane block vs spinal morphine for pain relief after Caesarean section.

 

Br J Anaesth, 2011. 106(5): p. 706-12.

 

inclusion criteria

– ASA physical status I/II/III

exclusion criteria

– history of relevant drug allergy

– tolerance to opiates

– BMI >35 kg/m2

– pre-eclampsia

– contraindication to neuraxial anaesthesia

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

SMTS: 33 ± 4

SMTLA: 34 ± 6

SSTLA: 33 ± 5

SSTS: 34 ± 5

maternal weight [kg]: mean ± SD

SMTS: 70 ± 13

SMTLA: 74 ± 14

SSTLA: 72 ± 14

SSTS: 66 ± 15

maternal height [cm]: mean ± SD

SMTS: 162 ± 7

SMTLA: 161 ± 5

SSTLA: 166 ± 6

SSTS: 162 ± 6

ASA physical status: median (IQR)

SMTS: 1 (1–1)

SMTLA: 1 (1–1)

SSTLA: 1 (1–1)

SSTS: 1 (1–1)

gestation (wk): mean ± SD

SMTS: 39 ± 1

SMTLA: 39 ± 1

SSTLA: 38 ± 2

SSTS: 39 ± 2

parity: median (IQR)

SMTS: 1 (1–2)

SMTLA: 1 (1–2)

SSTLA: 1 (1–1)

SSTS: 1 (0–1)

patient flow and follow up:

total patient number included:

80

randomised in:

SMTS: 20

SMTLA: 20

SSTLA: 20

SSTS: 20

excluded:

0

analysed:

all randomised patients analysed

follow-up:

48 hours

mode of anaesthesia

SpA: hyperbaric bupivacaine 11–12.5 mg with fentanyl 10 µg

SMTS:

spinal morphine 100 µg and

bilateral TAP block containing saline

SMTLA:

spinal morphine 100 µg and

bilateral TAP block containing bupivacaine 2 mg/kg

SSTLA:

spinal saline and

bilateral TAP block containing bupivacaine 2 mg/kg

SSTS:

spinal saline 100 µg and

bilateral TAP block containing saline

surgical approach

not reported

postoperative pain management

after surgery

rectal paracetamol 1 g and diclofenac 100  mg

afterwards

oral paracetamol 1 g 6 hourly,

rectal diclofenac 100 mg 18 hourly

IV morphine via (PCA):

1 mg bolus, 5 min lockout

postoperative pain at rest [mm]: median

at 6 h

SMTS: 16

SMTLA: 8.5*

SSTLA: 31**

SSTS: 29

* (p<0.05) versus SSTS

** (p<0.05) versus SMTLA

at 24 h

SMTS: 10*

SMTLA: 12

SSTLA: 26.5

SSTS: 20

* (p<0.05) versus SSTLA

at 48 h

no significant differences between the groups

postoperative pain on movement [mm]: median

at 6 h

SMTS: 27.5*

SMTLA: 20*

SSTLA: 52

SSTS: 51.5

* (p<0.05) versus SSTS

at 24 h

no significant differences between the groups

at 48 h

no significant differences between the groups

morphine consumption [mg]: median

at 6 h

SMTS: 4.0*

SMTLA: 5.0*

SSTLA: 8.0

SSTS: 12.0

* (p<0.05) versus SSTS

at 12 h

SMTS: 2.0*

SMTLA: 5.0

SSTLA: 10.5

SSTS: 6.0

* (p<0.05) versus SSTLA

at 24 h

SMTS: 6.0

SMTLA: 5.0

SSTLA: 15.0*

SSTS: 9.5

* (p<0.05) versus SMTLA

at 36 h

no significant differences between the groups

at 48 h

no significant differences between the groups

patient satisfaction

no significant differences between the groups

adverse effects/ events

sedation scores

no significant differences between the groups

mild pruritus

significantly more frequent in SMTLA at 6 h

methodological shortcomings

– generation of allocation sequence not reported

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“…spinal morphine reduces early pain after Caesarean section. TAP block does not provide comparable analgesia and does not provide additional benefit to spinal morphine. Therefore, TAP block as described in the study is of no therapeutic value for patients administered alone or in combination with spinal morphine. Additional studies using ultrasound and different drug combinations and doses of local anaesthetic for TAP block are warranted.”

reference participants’ characteristics intervention group/ control group

 

outcomes critical appraisal/ conclusion
Binder 2011

Hi-TENS combined with PCA-morphine as post caesarean pain relief.

 

Midwifery, 2011. 27(4): p. 547-552.

 

inclusion criteria

– no serious medical complications

– no tolerance to opiates

– gestational weeks 37–39

– singleton birth

– Apgar score >7 at one minute

– no complications immediately after childbirth

exclusion criteria

– not reported

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: median (IQR)

group TENS: 33 (27–37)

group CG: 33 (29–35)

gestational age [wk.]: mean

group TENS: 38

group CG: 38

previous c-section: n

group TENS: 11

group CG: 11

patient flow and follow up:

total patient number included:

50

randomised in:

group TENS: 25

group CG: 25

excluded:

group TENS:

– maternal complications: 1

– infant with complication: 1

– mother felt discomfort with TENS: 1

CG:

– maternal complications: 2

– infant with complication: 1

– undisclosed reasons: 2

analysed:

group TENS: 22

group CG: 20

follow-up:

24 hours

prior to anaesthesia

1 g paracetamol

mode of anaesthesia

SpA: with median 12.5 mg high density bupivacaine

surgical approach

not reported

after surgery

group TENS

for > 24 h:

Hi-TENS sensory level, by 2+2 electrode pads with two pads on each side along the wound, 2–3 cm distance from the wound

Two other electrode pads were placed on the upper part of the wound immediately after closure

Stimulator was set to high-frequency stimulation at 70 Hz, mother was instructed to adjust amplitude.

group CG

no Hi-TENS

postoperative pain management

1 g paracetamol every 6 h for at least 24 h

iPCA: morphine 5 mL (10 mg/mL) and 45 mL NaCl (set to 1 mg for each request, lock-out time 6 min, max. dosage per four hours was set to 35 mg)

rescue analgesia

bolus dose of 2–5 mg morphine

iPCA morphine consumption [mg]: mean ± SD (range)

group TENS: 16.2 ± 12.6 (0.0–45.5)

group CG: 33.1 ± 20.9 (2.0–91.0)

(p=0.008)

mean pain scores at rest [VAS]

no significant differences between the groups

(p>0.136)

rescue analgesia

no additional morphine was required

adverse effects/ events

sedation level over 24 h

significantly lower in group TENS

(p=0.045)

methodological shortcomings

– generation of allocation sequence not reported

– patients and outcome assessors not blinded

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“Pain relief from a combination of Hi-TENS and patient-controlled analgesia with morphine was as effective as patient-controlled analgesia with morphine alone, produced less sedation and reduced morphine use by approximately 50%. Women undergoing a caesarean section should be given the opportunity to make an informed choice about postoperative pain relief before surgery.”

Smith 1986

The effects of transcutaneous electrical nerve stimulation on post-cesarean pain.

 

Pain, 1986. 27(2): p. 181-193.

inclusion criteria

– multiparous

– aged >/=21 yr.

– English speaking

exclusion criteria

– regular narcotic use within 6 months prior to study

– mentally ill

– using cardiac pacemaker

– previous TENS exposure

demographic data:

maternal age [yr.]: mean

TENS: 30.5

noTENS: 28.0

(p=NS)

patient flow and follow up:

total patient number included:

18

randomised in:

TENS: 9

noTENS: 9

excluded:

0

analysed:

all randomised patients analysed

follow-up:

72 hours

mode of anaesthesia

EA or GA

(not specified)

surgical approach

not reported

postoperative pain management

TENS

first 48h: spike waveform impulses of 80 µ sec duration, delivered at a frequency of 85 Hz,

amplitude adjustable, ranging from 0 to 75 mA,

impulses were delivered to the skin, by a pair of 2.5 cm x 14 cm pre-gelled sterile electrodes

noTENS

first 48h: placebo stimulator identical to the real one, but the current activated only the indicator light and not the electrode leads

rescue analgesia

first 2448 h

meperidine 50–75 mg and promethazine 25 mg

thereafter

codeine 30–60 mg and acetaminophen 300–600 mg

postoperative pain reduced with TENS:

steady cutaneous incisional pain (pain rating index)

day of surgery: –

POD 1: <0.05

POD 2: NS

POD 3: NS

steady cutaneous incisional pain (present pain intensity scale)

day of surgery: NS

POD 1: <0.05

POD 2: <0.05

POD 3: NS

movement-associated cutaneous incisional pain (pain rating index)

day of surgery: –

POD 1: <0.01

POD 2: <0.001

POD 3: NS

movement-associated cutaneous incisional pain (present pain intensity scale)

day of surgery: <0.05

POD 1: <0.01

POD 2: <0.01

POD 3: NS

steady deep incisional pain (pain rating index)

day of surgery: –

POD 1: NS

POD 2: NS

POD 3: NS

steady deep incisional pain (present pain intensity scale)

day of surgery: NS

POD 1: NS

POD 2: <0.05

POD 3: NS

movement-associated deep incisional pain (pain rating index)

day of surgery: –

POD 1: NS

POD 2: NS

POD 3: NS

movement-associated deep incisional pain (present pain intensity scale)

day of surgery: NS

POD 1: NS

POD 2: NS

POD 3: NS

uterine contraction-associated pain (pain rating index)

day of surgery: –

POD 1: NS

POD 2: NS

POD 3: NS

uterine contraction-associated pain (present pain intensity scale)

day of surgery: NS

POD 1: NS

POD 2: NS

POD 3: NS

gas pain (present pain intensity scale)

day of surgery: –

POD 1: NS

POD 2: NS

POD 3: NS

need for additional analgesics [total number of doses/day]:

no significant differences between the two groups

methodological shortcomings

– no sample size calculation

– generation of allocation sequence not reported

– allocation concealment not reported

– selective outcome reporting

level of evidence: 2

authors’ conclusion

“…TENS was significantly more effective than placebo TENS in reducing cutaneous, movement associated incisional pain. However, pain resulting from internal structures, i.e., deep pain, afterbirth pain (due to uterine contractions), and the somatic pain associated with decreased peristalsis (gas pains) were not amenable to TENS. No significant differences in analgesic intake were observed.”

Kayman-Kose 2014Transcutaneous electrical nerve stimulation (TENS) for pain control after vaginal delivery and cesarean section.

 

J Matern Fetal Neonatal Med, 2014.

inclusion criteria

– healthy women who gave birth to healthy newborns

exclusion criteria

– patients with cardiac pacemakers

– morbid obesity

– epilepsy

– preeclampsia/ eclampsia

– who used TENS previously

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

TENS: 27.7 ± 4.1

noTENS: 26.9 ± 6.6

maternal BMI [kg/m2]: mean ± SD

TENS: 26.8 ± 2.0

noTENS: 27.3 ± 2.0

gestational age [wk]: mean ± SD

TENS: 37.8 ± 2.2

noTENS: 37.8 ± 2.2

gravidity

TENS: 2.32 ± 1.2

noTENS: 2.39 ± 1.6

parity

TENS: 1.2 ± 0.9

noTENS: 1.2 ± 1.1

patient flow and follow up:

total patient number included:

100

randomised in

TENS: 50

noTENS: 50

excluded:

0

analysed:

all included patients analysed

follow-up:

8 hours

mode of anaesthesia

GA: not specified

surgical approach

not reported

postoperative pain management

TENS

once for 30 min after childbirth

applied at 100 Hz frequency starting from 0 mA, stabilised at current value for which the patient felt

optimal relief without any discomfort

noTENS (placebo)

once for 30 min after childbirth

placebo: no electrical current was transmitted

IM diclofenac 75 mg 30 min after delivery

supplemental analgesia

not specified

postoperative pain: mean ± SD

VAS        before TENS     after TENS

TENS     82.8 ± 25.9        17.7 ± 12.7

placebo  87.5 ± 14.1        37.4 ± 20.6

p-value  (p=0.12)            (p<0.001)

VNS       before TENS     after TENS

TENS     7.6 ± 1.8           2.0 ± 1.8

placebo  8.4 ± 1.4           4.6 ± 1.4

p-value  (p=0.16)            (p<0.001)

need for supplemental analgesia at 8 h

TENS: 37 (74%)

placebo: 47 (94%)

(p=0.006)

methodological shortcomings

– no sample size calculation

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“TENS is an effective, reliable, practical, easily available and relatively cheap modality of treatment for postpartum pain. Further research is needed to achieve standardisation about the accomplishment of TENS after vaginal delivery or cesarean section.”

reference participants’ characteristics intervention group/ control group

 

outcomes critical appraisal/ conclusion
Bamigboye 2009

Local anaesthetic wound infiltration and abdominal nerves block during caesarean section for postoperative pain relief.

 

Cochrane Database Syst Rev, 2009(3): p. Cd006954.

databases/ search engines

– Cochrane Pregnancy  and Childbirth Group’s Trials Register

– Central

– Pubmed/ Medline

– hand searches of 30 journals

search period

through 04.2009

inclusion criteria

– randomised controlled trials

– comparing pre-emptive local analgesia:

1) local anaesthetic agent wound infiltration versus placebo/ no infiltration

2) Ilioinguinal/ iliohypogastric  nerve block versus placebo/ no treatment

3) local anaesthetic agent vs other methods of pain relief

4) comparison of different local anaesthetic agent techniques

included studies (n participants)

[1] Bamigboye 2008 (100)

[2] Bell 2002 (59)

[3] Caulry 2003 (10)

[4] Chen 1990 (36)

[5] Ganta 1994 (62)

[6] Givens 2002 (36)

[7] Kumar 1999 (50)

[8] Kuppuvelamini 1992 (60)

[9] Lacrosse 2004 (55)

[10] Lavand’homme 2007 (90)

[11] Marbaix 2004 (55)

[12] McDonnell 2008 (50)

[13] Mecklem 1995 (79)

[14] Pavy 1994 (40)

[15] Pirbudak 2004 (60)

[16] Rosaeg 1997 (40)

[17] Solak 1999 (30)

[18] Trotter 1991 (28)

[19] Zohar 2002 (50)

[20] Zohar 2006 (90)

[1] Bamigboye 2008

IG: 225 mg ropivacaine if >/=64 kg and 3 mg/kg if less,

CG: equivalent volume of saline,

all layers of the anterior abdominal incision infiltrated including the peritoneum,

postoperatively: pethidine, diclofenac injection and paracetamol/tramadol

[2] Bell 2002

IG: ilioinguinal-iliohypogastric nerve block with 0.5% bupivacaine with adrenaline,

CG: saline placebo

[3] Caulry 2003

IG1: ropivacaine

IG2: diclofenac

CG: saline

wound irrigation in each group

[4] Chen 1990

IG1: plain marcaine

IG2: marcaine with adrenaline

CG: no treatment

ilioinguinal nerve block after caesarean section

[5] Ganta 1994

IG: bilateral ilioinguinal nerve block with 0.5% bupivacaine

CG1: wound infiltration with 0.5% bupivacaine,

CG2: no local anaesthetic

[6] Givens 2002

IG: wound irrigation with 0.25% bupivacaine,

CG:  normal saline solution irrigation

[7] Kumar 1999

IG: pre-incisional 40 mL of 0.5% bupivacaine,

CG: 40 mL of bupivacaine and 2 mg morphine mixture

[8] Kuppuvelamini 1992

IG: mixture of 0.5% bupivacaine with adrenaline with 1% xylocaine injected to block the ilioinguinal/iliohypogastric,

CG: no abdominal nerve block

[9] Lacrosse 2004 (55)

IG1: wound irrigation with 300 mg of diclofenac for 48 h,

IG2:ropivacaine 0.2%,

CG: saline control

[10] Lavand’homme 2007

continuous wound infiltration of:

IG1: diclofenac,

IG2: 0.2% ropivacaine

CG: saline

[11] Marbaix 2004

IG: wound irrigation with 300 mg of diclofenac for 48 h,

CG1: ropivacaine 0.2%,

CG2: saline

[12] McDonnell 2008

IG: 1.5 mg/kg ropivacaine, per side injection into the transversus abdominis plane

CG: saline TAP block

[13] Mecklem 1995

IG: 0.25% bupivacaine

CG: saline

[14] Pavy 1994

IG: 0.5% bupivacaine,

CG: saline

[15] Pirbudak 2004

IG: 40 mL of 0.25% bupivacaine + 100 mg tramadol + 20 mg tenoxicam,

CG: normal saline

[16] Rosaeg 1997

both groups received 0.75% bupivacaine spinal analgesia:

IG: IT morphine, incisional bupivacaine and ibuprofen and acetaminophen,

CG: IV morphine weaned to acetaminophen and codeine

[17] Solak 1999

IG: 20 mL of 0.5% bupivacaine,

CG: saline

[18] Trotter 1991

IG: 0.5% bupivacaine,

CG: saline

[19] Zohar 2002

multi-holed device placed in wound and connected to a PCA:

IG: bupivacaine,

CG: combined with ketamine

[20] Zohar 2006

IG1: wound instillation via a patient-controlled analgesic infusion pump of 0.25% bupivacaine and 75 mg intravenous diclofenac.

CG1: only bupivacaine instillation,

CG2: only diclofenac infusion

wound infiltration with local anaesthetic only versus control

wound infiltration associated with:

reduced morphine consumption at 24 h: SMD (95% CI)

-1.70 mg (-2.75;-0.94) [3,6,13]

no difference in pain scores at 24 h: MD (95% CI)

-0.39 (-1.72;0.94) [3,6]

wound infiltration with local anaesthetic and peritoneal spraying versus placebo

local anaesthetic and peritoneal spraying associated with:

reduced need for pethidine rescue within 1 h: Risk ratio (95%)

0.51 (0.38;0.69) [1]

reduced pain scores at 1 h: MD (95% CI)

-1.46 (-2.60;-0.32) [1]

similar pain scores at 8 h: MD (95% CI)

-0.58 (-3.29;2.13) [1]

similar pain scores at 24 h: MD (95% CI)

0.19 (-0.67;1.05) [1]

similar consumption of total pethidine at 24 h: MD (95% CI)

-44.0 (-108.31;20.31) [1]

reduced consumption of tramacet: MD (95% CI)

-2.35 (-3.62;-1.08) [1]

wound infiltration with local anaesthetic + nonsteroidal anti-inflammatory drugs versus control

associated with:

similar no of attempts to activate PCA: MD (95% CI)

-15.0 (-30.22;0.22) [20]

reduced total morphine [mg] used in the first 18 h: MD (95% CI)

-7.4 (-9.58;-5.22) [20]

similar occurrence of nausea: risk ratio (95% CI)

1.40 (0.9;2.16) [16]

increased occurrence of pruritus: risk ratio (95% CI)

1.81 (1.01;3.23) [16]

abdominal nerve blocks with local anaesthetic versus placebo block or no block

associated with:

lower pain scores [VAS] at 24 h: MD (95% CI)

-1.82 (-2.74;-0.9) [2,4]

reduced postoperative opioid use [mg]: MD (95% CI)

-25.80 (-50.39;-1.21) [2,4,5,12]

wound infiltration with local anaesthetic versus local anaesthetic + narcotics

associated with:

similar pain scores at 2 h: MD (95% CI)

0.69 (-0.08;1.46) [7]

similar pain scores at 12 h: MD (95% CI)

0.18 (-0.59;0.95) [7]

similar pain scores at 24 h: MD (95% CI)

-0.15 (-0.92;2.94) [7]

wound infiltration with local anaesthetic versus local anaesthetic + ketamine

associated with:

similar total morphine consumption </=6 h: MD (95% CI)

0.10 (-2.74;2.94) [19]

 

methodological shortcomings

– publication bias not assessed

level of evidence: 1

authors’ conclusion

“Local analgesia infiltration and abdominal nerve blocks as adjuncts to regional analgesia and general anesthesia are of benefit in caesarean section by reducing opioid consumption. Nonsteroidal anti-inflammatory drugs as an adjuvant may confer additional pain relief.”

Carvalho 2010

Continuous subcutaneous instillation of bupivacaine compared to saline reduces interleukin 10 and increases substance P in surgical wounds after cesarean delivery.

 

Anesth Analg, 2010. 111(6): p. 1452-9.

 

 

inclusion criteria

– ASA physical status I/ II

– gestational age>37 weeks

– singleton pregnancies

exclusion criteria

– twin pregnancy

– BMI >40 kg/m2

– emergency caesarean delivery

– postpartum tubal ligation

– any contraindication to neuraxial anaesthesia

– hypersensitivity

-previous reaction to opioid medications

– history of chronic opioid use

– intolerance to (NSAIDs)

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean

group Bupi: 35 ± 4

group P: 35 ± 5

height [cm]: mean ± SD

group Bupi: 165 ± 8

group P: 164 ± 6

weight [kg]: mean ± SD

group Bupi: 79 ± 18

group P: 77 ± 15

nulliparous: [%]

group Bupi: 26

group P: 21

previous caesarean delivery [%]

group Bupi: 74

group P: 74

gestational age [wk]: median (range)

group Bupi: 39 (38–39)

group P: 38 (38–39)

patient flow and follow up:

total patient number included:

38

randomised in:

group Bupi: 19

group P: 19

excluded:

0

analysed:

all randomised patients analysed

follow-up:

48 hours

mode of anaesthesia

SpA: IT hyperbaric bupivacaine 12 mg, IT fentanyl 10 µg, and IT morphine 200 µg

surgical approach

not reported

before wound closure

On-Q Pain-Buster Post-Op Pain Relief System inserted subcutaneously to deliver:

group Bupi:

bupivacaine 5 mg/mL for 24 h

group P:

normal saline at 2 mL/h for 24 h

postoperative pain management

supplemental analgesia

oral ibuprofen 600 mg every 6 h for 48 h

rescue analgesia

oral oxycodone 5 mg (</=60 mg/24 h) with acetaminophen 325 mg tablets (</=4 g/24 h),

(1 to 2 tablets every 4 h)

for severe pain:

IV morphine

postoperative pain

AUC NVPS at rest 0–48 h:

group Bupi: 47 (31–92)

group P: 45 (9–78)

(p=NS)

AUC NVPS activity 0–48 h:

group Bupi: 173 (135–195)

group P: 140 (105–212)

(p=NS)

need for supplemental analgesia [mg]: median (IQR)

0–24 h

group Bupi: 7.5 (5–10)

group P: 5 (0–15)

(p=NS)

24–48 h

group Bupi: 15 (8–24)

group P: 10 (4–18)

(p=NS)

need for rescue analgesia

oral opiod analgesia: n (%)

group Bupi: 19 (100)

group P: 16 (84)

(p=NS)

IV morphine analgesia: n (%)

group Bupi: 1 (5)

group P: 1 (5)

(p=NS)

methodological shortcomings

– no sample size calculation

– allocation concealment not reported

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“Subcutaneous surgical wound infiltration with bupivacaine 5 mg/mL compared with saline at 2 mL/h for 24 h resulted in similar postoperative pain scores and need for supplemental and rescue analgesia”

Fouladi 2013

Pre-incisional, post-incisional and combined pre- and post-incisional local wound infiltrations with lidocaine in elective caesarean section delivery: a randomised clinical trial.

 

J Obstet Gynaecol, 2013. 33(1): p. 54-9.

inclusion criteria

– ASA physical status I/ II

– >/=37 weeks’ gestation

– age between 23 and 36 years

– uncomplicated singleton pregancy

exclusion criteria

– history of maternal medical or obstetric illness

– any evidence of fetal compromise within the current pregnancy

– prior surgery in the operative site

– allergy to medications

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD (range)

pre: 27.00 ± 3.45 (24–35)

post: 28.79 ± 3.11 (23–36)

mixed: 29.09 ± 4.22 (23–36)

weight [kg]: mean ± SD (range)

pre: 70.61 ± 7.60 (58–84)

post: 72.07 ± 5.23 (53–87)

mixed: 73.19 ± 4.29 (51–92)

height [cm]: mean ± SD (range)

pre: 163.24 ± 5.28 (151–175)

post: 164.55 ± 4.29 (152–177)

mixed: 165.21 ± 5.32 (151–181)

gravidity: mean ± SD (range)

pre: 1.98 ± 0.66 (1–4)

post: 2.02 ± 0.55 (1–4)

mixed: 1.89 ± 0.43 (1–3)

operating time: mean ± SD (range)

pre: 46.61 ± 5.65 (39–55)

post: 47.29 ± 4.31 (38–57)

mixed: 46.76 ± 5.09 (39–61)

patient flow and follow up:

total patient number included:

300

randomised in:

pre: 100

post: 100

mixed: 100

excluded: 19

pre: 6

post: 8

mixed: 5

analysed: 281

pre: 94

post: 92

mixed: 95

follow-up:

24 hours

mode of anaesthesia

SpA: 60–70 mg of 5% lidocaine (1.2–1.5 mL)

surgical approach

not reported

pre:

infiltrated with anaesthetic mixture containing 1% lidocaine with 1:100,000 adrenaline 5 min before incision,

surrounding subcutaneous tissues infiltrated with the anaesthetic solution (20 mL)

post:

fascia and subcutaneous tissues around incision wound, and abdominal rectus muscle infiltrated

with the same anaesthetic solution (20 mL).

mixed:

both the pre-incisional and post-incisional infiltrations performed together in the same ways mentioned before but with one half volume of the local anaesthetic mixture (total volume = 20 mL).

postoperative pain management

supplemental analgesia

in recovery room

IV morphine 5 mg at request

thereafter

diclofenac sodium 100 mg (50 mg rectal suppository) rectally every 8 h.

rescue analgesia

IM morphine 5 mg

postoperative pain

VAS pre versus post

significantly reduced in pre in recovery room, at 12 and 24 h, but not at 30 min, 1, 2, 3, and 6 h

VAS pre versus mixed

significantly reduced in mixed in all time points

VAS post versus mixed

significantly reduced in mixed in all time point except for recovery room

time to first analgesic request [h]: mean ± SD

pre: 2.89 ± 2.01

post: 3.27 ± 2.02

mixed: 4.49 ± 3.09*

* (p<0.05) mixed compared with pre and post

need for rescue analgesia [demands]: mean ± SD

pre: 1.61 ± 0.72

post: 1.62 ± 0.51

mixed: 1.40 ± 0.52*

* (p<0.05) mixed compared with post

time to ambulation [h]: mean ± SD

pre: 9.26 ± 2.43

post: 9.10 ± 1.98

mixed: 8.79 ± 2.09

(p=NS)

Apgar score: mean ± SD

at 1 min

pre: 8.86 ± 0.41

post: 8.90 ± 0.33

mixed: 8.83 ± 0.51

(p=NS)

at 5 min

pre: 9.67 ± 0.47

post: 9.73 ± 0.45

mixed: 9.66 ± 0.48

(p=NS)

methodological shortcomings

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“combined pre- and post-incisional local wound infiltrations with lidocaine was superior to each one alone in reducing pain and postoperative analgesic requirements in pregnant women undergoing elective caesarean section”

Behdad 2013

Comparison of postoperative analgesic effect of tramadol and bupivacaine subcutaneous infiltration in patients undergoing cesarean section.

 

Acta Clin Croat, 2013. 52(1): p. 93-7.

 

inclusion criteria

not reported

exclusion criteria

– known allergy/ hypersensitivity to tramadol

– systemic diseases (cardiopulmonary disease, diabetes, hypertension)

– neurologic disorder

– preeclampsia and chronic use of narcotics or substance abuse

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group tramadol: 26.7 ± 5.1

group Bupi: 28.1 ± 7.9

parity: primiparous [n (%)]/ multiparous [n (%)]:

group tramadol: 12 (40)/ 18 (60)

group Bupi: 10 (33.3)/ 20 (66.7)

gestational age [wk]: mean ± SD

group tramadol: 38.6 ± 1.3

group Bupi: 38.4 ± 1.6

indication [n (%)]: repeated/ cephal. disprop/ other

group tramadol: 19 (63.3)/ 5 (16.7)/ 6 (20)

group Bupi: 16 (53.4)/ 7 (23.3)/ 7 (23.3)

operating time [min]: mean ± SD

group tramadol: 60.4 ± 15.3

group Bupi: 61.8 ± 16.8

patient flow and follow up:

total patient number included:

60

randomised in:

group tramadol: 30

group Bupi: 30

excluded:

0

analysed:

all randomised women analysed

follow-up:

24 hours

mode of anaesthesia

GA:

induced with

thiopental 5 mg/kg  and succinylcholine 1–1.5 mg/kg;

maintained with

0.5 MAC isoflurane, 50% O2, 50% N2O

surgical approach

Pfannenstiel and Kerr incision

postoperative pain management

before skin closure

group tramadol:

subcutaneous wound infiltration with 50 mg of tramadol in 10 mL normal saline

group Bupi:

subcutaneous wound infiltration with 10 mL of 0.5% bupivacaine

after delivery:

fentanyl 2 µg/kg

 

 

postoperative pain

VAS: mean ± SD

                group tramadol    group Bupi        p-value

at 1 h      5.13 ± 0.93            5.53 ± 1.52       0.12

at 2 h      5 ± 1.17                 5.57 ± 1.22       0.11

at 6 h      3.83 ± 1.08            4.73 ± 1.25       0.004

time to first analgesic request [h]: mean ± SD

group tramadol: 6.6 ± 3.98

group Bupi: 4.66 ± 3.66

(p=0.04)

women requiring more analgesia </=24 h [n (%)]

group tramadol: 11 (36.67)

group Bupi: 20 (66.67)

(p=0.006)

total pentazocine consumption </=24 h [mg]: mean ± SD

group tramadol: 42.9 ± 24.3

group Bupi: 37.8 ± 17.4

(p=0.03)

recovery

hospital stay [h]: mean ± SD

group tramadol: 60.1 ± 8.2

group Bupi: 62.3 ± 9.1

(p=0.24)

adverse effects/ events: n (%)

                group tramadol      group Bupi           p-value

nausea       6 (20)                  8 (26.7)                0.37

vomiting     4 (13.3)               7 (23.3)                0.23

hypotens.   0                          0                          –

cardiov.      0                          0                          –

 

methodological shortcomings

– no methodological shortcomings according to the evaluation sheet

level of evidence: 1

authors’ conclusion

“… subcutaneous infiltration of tramadol provided analgesic effect equal to bupivacaine but with longer pain relief after cesarean section. We conclude that tramadol may be a good choice

for local anesthesia after surgery”

Fredman 2000

The analgesic efficacy of patient-controlled ropivacaine instillation after cesarean delivery

 

Obstetric Anesthesia, 2000. 91: p. 1436-1440

 

 

inclusion criteria

not reported

exclusion criteria

– history of clinically significant cardiovascular, pulmonary, hepatic, renal, neurologic, psychiatric, or metabolic disease

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group R: 32 ± 5

group P: 30 ± 4

maternal height [cm]: mean ± SD

group R: 162 ± 8

group P: 165 ± 5

maternal weight [kg]: mean ± SD

group R: 81 ± 15

group P: 72 ± 25

gravity: mean ± SD

group R: 3 ± 1

group P: 3 ± 1

parity: mean ± SD

group R: 1 ± 1

group P: 2 ± 1

patient flow and follow up:

total patient number included:

50

randomised in:

group R: 25

group P: 25

excluded:

0

analysed:

all patients analysed

follow-up:

24 hours

 

preanaesthetic medication:

– PO effervescent cimetidine

before anaesthesia:
10-15 mL/ kg lactated Ringer’s solution

mode of anaesthesia

SpA: hyperbaric bupivacaine 8–10 mg

surgical approach

Pfannenstiel incision

postoperative pain management

elastometric pump:

multi-hole 20-gauge epidural catheter inserted above the fascia with the catheter tip sited at the point that demarcated 50% of the length of the surgical wound,

using an aseptic technique, the catheter connected to the elastometric pump

group R:

wound instillation with 0.2% ropivacaine 100 mL

group P:

wound instillation with sterile water

 

all patients in PACU

PO dipyrone 1 g

rescue analgesia

IV morphine 2 mg at 10 min until VAS</=30 mm for first 6 h,

afterwards oral dipyrone 1 g

number of pump infusions: mean ± SD

group R                  group P

total*                       7 ± 2                       4 ± 1

0–6 h                      4 ± 1                       3 ± 1

6–24 h*                  3 ± 2                       1 ± 1

* (p<0.01)

total volume infused via pump (24 h): mean ± SD

group R: 67 ± 22

group P: 42 ± 14

(p<0.01)

rescue morphine administration:

group R                group P

number of patients*                12 (48%)               23 (92%)

number of 2 mg doses/ pat.*  1 ± 2                      4 ± 3

total morphine [mg/6 h]*         2 ± 3                      10 ± 5

rescue dipyrone [1 g]              1 ± 1                      1 ± 1

*(p<0.01)

postoperative pain [VAS]

pain at rest

no differences between the two groups between first 6 h and at removal of catheter

pain during coughing

significantly reduced in group R between 3 and 6 h, but not before, and at removal of catheter

pain during leg raising

significantly reduced in group R between 3 and 6 h, but not before, and at removal of catheter

recovery

hospitalization time [days]: mean ± SD

group R: 5 ± 1

group P: 5 ± 1

patient satisfaction with analgesia

group R*                   group P

excellent         6                              0

good               15                           12

satisfactory     4                              10

poor                0                              3

*(p=0.0008), comparing two groups

methodological shortcomings

– generation of allocation sequence not reported

– selective outcome reporting

– no sample size calculation

level of evidence: 1

authors’ conclusion

“All patients stated that the elastometric pump was easy to use. Ropivacaine wound instillation via an elastometric pump is a simple technique that provides safe and effective analgesia after cesarean delivery.”

O”Neill 2012

Ropivacaine continuous wound infusion versus epidural morphine for postoperative analgesia after cesarean delivery: A randomized controlled trial.

 

Anesthesia and Analgesia, 2012. 114(1): p. 179-185.

 

inclusion criteria

– aged between 18 and 50 yr.

– gestational age: 37–42 weeks

– BMI: 18–30

– ASA physical status I/ II

– Pfannenstiel incision

exclusion criteria

– history of chronic opioid use

– >1 prior caesarean delivery

– contraindication to neuraxial anaesthesia

– physical separation of patients from the neonate during the postoperative period

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group W: 33 ± 5

group E: 33 ± 5

maternal BMI [kg/m2]: mean ± SD

group W: 29.3 ± 0.6

group E: 27.4 ± 0.9

nulliparous: n (%)

group W: 21 (72)

group E: 22 (76)

primary caesarean delivery: %

group W: 25 (86)

group E: 24 (83)

intraoperative bupivacaine [mg]: mean ± SD

group W: 8.7 ± 0.5

group E: 9.1 ± 0.3

intraoperative sufentanil [µg]: mean ± SD

group W: 2.1 ± 0.2

group E: 2.3 ± 0.1

patient flow and follow up:

total patient number included:

67

randomised in:

group W: 35

group E: 32

excluded:

group W: 6

– did not receive allocated intervention: 3

– accidental removal of catheter: 3

group E: 3

– refusal of epidural analgesia due to vomiting: 3

analysed: after 48 h (after 3 months)

group W: 29 (26)

group E: 29 (24)

follow-up:

48 hours and 3 months

mode of anaesthesia

group W:

SpA: single shot of hyperbaric bupivacaine and sufentanil (not specified)

group E:

CSEA: hyperbaric bupivacaine and sufentanil (not specified)

surgical approach

Pfannenstiel incision and peritoneal closure (not specified)

postoperative pain management

group W:

wound catheter placed below the fascia:

initial dose of 10 mL ropivacaine 10 mg/mL. followed by continuous infusion of ropivacaine 2 mg/mL at 5 mL/h for 48 h

group E:

2 mg/10 mL bolus of epidural morphine every 12 h (4 times)

supplemental analgesia

both groups:

paracetamol 1 g IV every 6 h for 48 h

rescue analgesia

diclofenac 75 mg (</=4 daily) IM

postoperative pain [VAS]

at rest

significantly reduced in group W at 2, 6, 24 and 48 h

on movement

significantly reduced in group W at 2 and 6 h, but not at 24 and 48 h

consumption of rescue analgesia: median (IQR)

group W: 0 (0, 1)

group E: 0 (0, 1)

(p=NS)

3 month postoperative patient satisfaction: median (IQR)

group W: 8 (8; 10)

group E: 9 (6, 9)

(p=0.37)

recovery

fullfillment of discharge criteria

at 24 h: n

group W: 25

group E: 0

(p<0.001)

adverse effects/ events

PONV: n

group W: 0

group E: 11

(p<0.001)

pruritus: n

group W: 6

group E: 17

(p=0.007)

urinary retention: n

group W: 0

group E: 13

(p<0.001)

gastrointestinal function reestablishment at 48 h: n

group W: 25

group E: 14

(p=0.005)

 

 

methodological shortcomings

– no blinding

level of evidence: 1

authors’ conclusion

“… continuous wound infusion with ropivacaine through a catheter placed below the fascia, after an initial loading dose, provided better analgesia with fewer side effects then intermittent epidural morphine analgesia.”

Demiraran 2013

Tramadol and levobupivacaine wound infiltration at Cesarean delivery for postoperative analgesia.

 

Journal of Anesthesia, 2013. 27(2): p. 175-179.

 

inclusion criteria

– ASA physical status I/ II

exclusion criteria

– history of previous local anaesthetic events

– hypertension in pregnancy with proteinuria

– cardiac diseases

– any other major medical disorder associated with pregnancy

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group P: 27.8 ± 5.2

group L: 26.5 ± 4.4

group T: 25.6 ± 4.7

maternal weight [kg]: mean ± SD

group P: 79.5 ± 10.0

group L: 77.7 ± 9.3

group T: 80.6 ± 10.2

maternal height [cm]: mean ± SD

group P: 160.9 ± 4.0

group L: 161.0 ± 5.1

group T: 162.0 ± 3.8

primary caesarean delivery: n (%)

group P: 23 (76)

group L: 24 (80)

group T: 22 (73)

nulliparous: n (%)

group P: 18 (60)

group L: 17 (56)

group T: 20 (66)

patient flow and follow up:

total patient number included:

90

randomised in:

group P: 30

group L: 30

group T: 30

excluded:

0

analysed:

all included patients analysed

follow-up:

24 hours

mode of anaesthesia

GA: induced with thiopental 4–6 mg/kg and atracurium 0.5 mg/kg, maintained with 1.5–2% sevoflurane and 50% N2O-50% O2 mixture at 5 L/min

surgical approach

Pfannenstiel incision (not specified)

postoperative pain management

at the end of surgery: local wound infiltration subcutaneously of 20 mL solution along the skin wound edges and the skin approximated with a subcutaneous absorbable 3-0 polyglecaprone suture

group P:

20 mL with 0.9% saline solution

group L:

20 mL with 0.25% levobupivacaine solution

group T:

20 mL with tramadol 1.5 mg/kg within 0.9% saline solution

supplemental analgesia

tramadol via PCA: loading dose: total of repeated 20 mg bolus doses every 3 min until VAS </=3, basal infusion rate: 5 mg/h, bolus dose: 20 mg, lockout 15 min; bolus dose increased to 25 mg in patients with VAS>3

rescue analgesia

diclofenac 75 mg IV

postoperative pain [VAS]: mean ±SD

at rest       group P     group L      group T

15 min      7.7 ± 1.8    4.6 ± 1.3     4.5 ± 1.3*

2h             2.7 ± 1.3    2.2 ± 1.2     2.6 ± 1.7

*p=0.001

movement    group P     group L    group T

4 h                1.7 ± 1.0    2.0 ± 1.4   1.8 ± 1.2

8 h                1.5 ± 1.3    1.6 ± 1.3   1.5 ± 1.1

12 h              1.5 ± 1.3    1.7 ± 1.5   1.4 ± 0.9

16 h              0.9 ± 0.5    1.4 ± 1.2   1.0 ± 0.6

20 h              1.0 ± 1.1    1.2 ± 1.2   0.7 ± 0.6

24 h               0.4 ± 0.5    0.7 ± 0.7   0.4 ± 0.5

(p=NS)

tramadol consumption [mg] 24 h: mean ± SD

group P: 557.5 ± 76.9

group L: 401.6 ± 105.3*,**

group T: 483.3 ± 120.0*

* among all groups p=0.001

** between groups T and L p=0.007

rescue diclofenac consumption [mg]: mean ± SD

group P: 17.5 ± 32.2

group L: 10.0 ± 25.9

group T: 17.5 ±32.2

(p=NS)

adverse effects/ events

                               group P     group L     group T

pruritus                   2                 3               2

vomiting                  4                5               5

temp. >38°C           0                 1              2

wound infection      1                 0              0

(p=NS)

methodological shortcomings

no methodological shortcomings according to the evaluation sheet

level of evidence: 1

authors’ conclusion

“…wound infiltration with tramadol and levobupivacaine in patients having caesarean section under general anaesthesia may be a good choice for postoperative analgesia.”

Kainu 2012

Continuous wound infusion with ropivacaine fails to provide adequate analgesia after caesarean section.

 

International Journal of Obstetric Anesthesia, 2012. 21(2): p. 119-124.

 

inclusion criteria

– Pfannenstiel incision under combined spinal-epidural anaesthesia

exclusion criteria

– ASA physical status III/IV

– significant co-existing disease

– preeclampsia

– intrahepatic cholestasis of pregnancy

– allergy to study drugs

– major haemorrhage (>1500 mL)

– BMI >35

– refusal to participate

– if >8 mL of lidocaine during surgery

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean (range)

group M: 33 (23–42)

group R: 33 (25–41)

group P: 32 (23–40)

height [cm]: mean (range)

group M: 167 (156–187)

group R: 167 (157–178)

group P: 166 (156–178)

weight [kg]: mean (range)

group M: 80 (59–102)

group R: 78 (63–99)

group P: 77 (63–113)

nullipara n/ multipara n

group M: 10/ 14

group R: 10/ 12

group P: 9/ 11

gestational age (wk.): mean (range)

group M: 39 (38–42)

group R: 39 (38–41)

group P:39 (36–41)

patient flow and follow up:

total patient number included:

66

randomised in:

group M: 24

group R: 22

group P: 20

excluded: two from each group

– significant leakage of fluid from the wound catheter: 2

– wound haematoma: 1

– bleeding from the uterus: 1

– catheter accidentally removed: 1

– left study due to infant with heart anomaly: 1

analysed:

unclear: data collected before interruption used in the analysis

follow-up:

24 hours

mode of anaesthesia

CSEA: isobaric bupivacaine 10 mg (2.0 mL) combined with fentanyl 15 µg (0.3 mL) and either saline (0.4 mL) or morphine (160 µg) according to randomisation, additional lidocaine (20 mg/mL) as needed,

1000 mL of acetated Ringer’s solution,

ephedrine and/or phenylephrine as needed

surgical approach

Pfannenstiel incision and transverse lower uterine segment incision,

depending on haemostasis, the uterus was closed with one or two layers of continuous absorbable suture,

the peritoneum and muscles were left open and the fascia was closed with a running continuous suture of absorbable material,

skin was closed with non-absorbable individual stitches (removed on day five or six)

postoperative pain management

group M:

IT morphine 160 µg (0.4 mL) and saline wound infiltration at 5 mL/h

group R:

IT saline 0.4 mL and wound infiltration with 0.375% ropivacaine at 5 mL/h

group P:

saline was administered both intrathecally and by wound infiltration

supplemental analgesia

all patients

oral ketoprofen 100 mg three times a day and oxycodone via iPCA for 24 h (bolus of 2 mL, lockout 8 min, max. 32 mg/4 h),

after 24 h: oral oxycodone (5 or 10 mg) on demand

consumption of oxycodone [mg]: mean ± SD

for 24 h

group M: 26 ± 21

group R: 48 ± 23**

group P: 45 ± 23*

*p=0.021 between group M and group P

**p=0.007 between group M and group R

(p=NS) between group R and group P

24–48 h

group M: 15 (n. r.)

group R: 12 (n. r.)

group P: 15 (n. r.)

(p=NS)

postoperative pain at rest [VAS]: mean ± SD

during first 24 h

group M: 1.3 ± 1.2*

group R: 1.7 ± 0.8

group P: 2.2 ± 1.3

* significant lower in group M compared to group P (p=0.021), but no significant differences between group M and group R or group R and group P

significant differences at 6, 9 and 12 h but not at 2, 3, 15, 18, 21, 24 h

from 24 h to 48 h

group M: 2.1 ± 1.2

group R: 2.4 ± 1.0

group P: 2.2 ± 1.3

(p=NS)

adverse effects/ events

pruritus

significantly more common in group M compared to group R and group P at 2, 3 and 6–12 h (p=0.04, p=0.04 and p=0.009, respectively), but not during surgery, 12–24 and 24–48 h

PONV

no significant differences between the groups on POD 1 and POD 2

recovery

spontaneous voiding [h]: mean ± SD

group M: 2.4 ± 1.1*

group R: 3.5 ± 1.5

group P: 3.7 ± 1.2

* (p=0.004)

no significant differences concerning:

– flatus

– defecation within 48 h

– first successful lactation

– satisfaction with sleep first, second night and pain management

– discharge

– mean satisfaction scores

methodological shortcomings

– allocation concealment not reported

level of evidence: 1

authors’ conclusion

“…in the current study continuous wound infusion with ropivacaine failed to reduce PCA opioid consumption or pain scores when compared to both saline control with and without the addition of intrathecal morphine. However, intrathecal morphine resulted in a significant reduction in opioid consumption and, when compared to saline wound infusion, reduced pain scores. Pruritus was a common side effect in parturients receiving intrathecal morphine.”

Magnani 2006

Postoperative analgesia after cesarean section by continued administration of levobupivacaine with the On-Q Painbuster system over the fascia vs ketorolac + morphine IV

 

Clinical and experimental obstetrics & gynecology, 2006. 33(4): p. 223-225

 

exclusion criteria

– preterm gestation (< 36 weeks),

– intrauterine fetal death,

– multiple pregnancy,

– known or suspected fetal abnonnalities,

– breech presentation,

– ASA physical status III/IV,

– relative and absolute contraindications to regional anaesthesia

demographic data:

no significant differences in baseline characteristics

(data not shown)

patient flow and follow up:

total patient number included:

20

randomised in:

group A: 10

group B: 10

excluded:

0

analysed:

all included patients analysed

follow-up:

48 hours

mode of anaesthesia

SpA: isobaric 0.5% bupivacaine 10 mg with

sufentanyl 2.5 µg and

morphine 50 µg

surgical approach

not reported

postoperative pain management

group A:

IV morphine 10 mg + ketorolac 120 mg + normal saline up to 96 mL with an elastomeric pump

(infusion speed of 2 mL/h for 48 h)

group B:

local infusion of 0.2% levobupivacaine with On-Q PAINBUSTER system with catheter placed in subcutaneous layer

(infusion speed of 2 mL/h for 48 h)

supplemental analgesia

bolus of IV ketorolac 30 mg as needed

time to first analgesic request [min]: mean ± SD

group A: 455 ± 22

group B: 380 ± 30

(p<0.05)

postoperative pain scores

significantly less in group A compared with group B

(data not shown)

need for supplemental analgesics: n

significantly lower in group A than group B

(data not shown)

adverse effects/ events

nausea and itching

more cases in group A

no signs of

– local or general infection

– inflammatory infiltration

recovery

time to first mobilisation

no significant differences between the groups

methodological shortcomings

– generation of allocation sequence not reported

– allocation concealment not reported

– method of blinding not described

– no sample size calculation

– selective outcome reporting

level of evidence: 2

authors’ conclusion

“The IV system with morphine and ketorolac is more effective than levobupivacaine subcutaneous infusion in reducing postoperative pain associated with caesarean section”

 

Rackelboom 2010

Improving continuous wound infusion effectiveness for postoperative analgesia after cesarean delivery

 

Obstretrics and Gynecology; 2012. 116(4): p. 893-900.

 

inclusion criteria

– ASA physical status I/II

– <37 wk. of gestation

– Pfannenstiel incision

– spinal anaesthesia

exclusion criteria

– known allergy to NSAID

– ASA physical status III or higher

– refusal to participate

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group above: 33 ± 4

group below: 32 ± 6

height [cm]: mean ± SD

group above: 163 ± 6

group below: 164 ± 5

weight [kg]: mean ± SD

group above: 74 ± 13

group below : 76 ± 17

gravidity: mean ± SD

group above: 3 ± 1

group below: 3 ± 2

parity: mean ± SD

group above: 2.0 ± 1

group below: 2.5 ± 2

previous caesarean delivery [%]

group above: 64

group below: 52

patient flow and follow up:

total patient number included:

56

randomised in:

group above: 29

group below: 27

excluded: 6

group above

disconnection/ dysfunction of device: 2

wound leakage: 2

group below

disconnection/ dysfunction of device: 2

analysed:

group above: 25

group below: 25

follow-up:

48 hours

mode of anaesthesia

SpA: 2 mL of 0.5% hyperbaric bupivacaine (10 mg) with

sufentanil 5 µg,

morphine 100 µg

surgical approach

Joel Cohen approach without peritoneal closure

postoperative pain management

multihole 20-gauge catheter below the fascia or above the fascia (according to randomization):

group below

catheter positioned below the fascia between the unclosed parietal peritoneum and the underside of the transversalis fascia before its closure, along the full length of the wound.

group above

catheter set above the superficial abdominal fascia,

the surgeon closed the skin and secured the infusion catheter on the skin using a sterile tape without any difference regarding group allocation.

when wound was closed, a 10 mL bolus of sterile saline administered through the catheter,

catheter then connected to an elastomeric pump set to deliver 5 mL/h for 48 hours containing ropivacaine 450 mg and ketoprofene 200 mg in 240 mL isotonic saline.

supplemental analgesia

IV morphine via PCA

morphine 1.5 mg per demand,

lockout: 7 min, </=20 mg/4 h

supplemental morphine consumption

significantly reduced in group below at 12, 24, 36 and 48 h, but not at 3 and 6 h

(p<0.05)

postoperative pain [VAS]:

at rest

significantly reduced in group below at 3, 6, 12, 24, and 36 h, but not at 48 h

(p<0.05)

during movement

no differences between the two groups

residual pain or discomfort at 1 month

no difference between the two groups

(p=0.55)

residual pain or discomfort at 6 month

no difference between the two groups

(p=1)

adverse effects/ events

group above      group below                p-value

nausea/ vomiting

7 (28%)              6 (24%)                      0.74

itching

11 (44%)            12 (48%)                     0.77

satisfaction [0–10 scale]

group above: 8.6 ± 1.1

group below: 8.9 ± 1.3

(p=0.81)

recovery

hospital stay [days]: mean ±SD

group above: 6.1 ±1.2

group below: 6.3 ± 1.3

(p=0.72)

methodological shortcomings

no methodological shortcomings according to the evaluation sheet

level of evidence: 1

authors’ conclusion

“We show here that local anesthetic combined with NSAID are more effective for postoperative pain control after cesarean delivery when administered below the fascia rather than above. The mechanism of action requires further investigation, but the next studies comparing different analgesic modalities will have to integrate this current result.”

Ranta 2006

Incisional and epidural analgesia after caesarean delivery: a prospective, placebo-controlled, randomised clinical study

 

International Journal of Obstetric Anesthesia; 2006. 15: p. 189-194.

 

 

inclusion criteria

– ASA physical status I/II

– Pfannenstiel incision

– no contraindication to perispinal anaesthesia

– no allergy to any of the study medications

– no history of alcohol/drug abuse or major medical disease such as clinically significant cardiovascular, pulmonary, metabolic, renal, neurologic or psychiatric disease.

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group epi: 28 ± 5

group subfas: 29 ± 6

body mass index: mean ± SD

group epi: 30 ± 3

group subfas: 29 ± 5

gestation [weeks]: mean ± SD

group epi: 40 ± 1

group subfas: 39 ± 1

primipara/ multipara: [n]

group epi: 8/12

group subfas: 8/12

patient flow and follow up:

total patient number included:

40

randomised in:

group epi: 20

group subfas: 20

excluded: 7 after 24 h

group epi:

insufficient analgesia: 3

group subfas:

insufficient analgesia: 4

analysed: 33

group epi: 17

group subfas: 16

follow-up:

72 hours

preoperatively

epidural catheters inserted 5 cm into epidural space

mode of anaesthesia

SpA: hyperbaric bupivacaine (5 mg/mL)

intraoperative pain

IV alfentanil on request

surgical approach

Pfannenstiel incision

postoperative pain management

group epi:

intermittent 10 mL boluses of 0.125% levobupivacaine via an epidural catheter,

ten 10 mL syringes of epidural

levobupivacaine available,

at the same time 10 mL of physiologic saline administered into the wound as a placebo via a subfascial catheter by pressing the button of the balloon pump

group subfas:

10 mL boluses of 0.25% levobupivacaine via the subfascial wound catheter connected to the balloon pump,

10 mL boluses of physiologic saline as placebo were administered via

the epidural catheter

all patients

oral paracetamol 1 g/6 h

recue analgesia

IV oxycodone 0.05 mg/kg at 10 min interval (until VAS </=3)

intraoperative pain management

alfentanil [n]

group epi: 12/20

group subfas: 16/20

(p=NS)

alfentanil [mg]: mean ± SD

group epi: 0.38 ± 0.39

group subfas: 0.50 ± 0.11

(p=NS)

time to first request for analgesia [min]: mean ± SD

group epi: 32 ± 32

group subfas: 34 ± 26

(p=NS)

postoperative pain:

at rest

significantly lower in group epi during first 4 hours (p=0.006), but not afterwards

at walking

similar during 72 h

(p=NS)

volume of local anaesthetic [mL]: mean ±SD

group epi              group subfas          p-value

4 h           29 ± 10                   38 ± 12                  0.01

24 h         57 ± 15 (n=19)       41 ± 20 (n=16)        0.007

48 h         10 ± 7 (n=10)         8 ± 13 (n=8)            NS

72 h         10 (n=1)                 20 (n=1)                  NS

total vol.   86 ± 22                  83 ± 20                    NS

total dose  107 ± 28               206 ± 51                  <0.001

dose of opioid [mg]: mean ± SD

group epi               group subfas          p-value

4 h           11 ± 9 (n=14)          17 ± 11 (n=19)         NS

24 h         11 ± 12 (n=13)        17 ± 9 (n=14)           NS

48 h         13 ± 22 (n=12)        8 ± 3 (n=9)               NS

72 h         n=0                         16 (6,16,24) (N=3)    NS

total         32 ± 27                    37 ± 23                     NS

recovery

hospital stay [days]: median (min–max)

group epi: 5 (4–5)

group subfas: 5 (5–5)

(p=NS)

patient satisfaction

no differences between the groups

(p=NS)

adverse effects/ events

mild nausea [n]

group epi: 1

group subfas: 2

motor weakness

group epi: 1

group subfas: 0

methodological shortcomings

no methodological shortcomings according to the evaluation sheet

level of evidence: 1

authors’ conclusion

“… incisional local analgesia administered via a subfascial catheter after caesarean delivery provided satisfactory analgesia without clinically significant side effects. The technique was easy to use, and patient satisfaction scores were comparable to that attained with epidural analgesia. Thus, incisional local analgesia as a component of multimodal pain management may be a good alternative to the more invasive epidural technique. It can also be a good choice for patients undergoing caesarean section under general anaesthesia. Further studies are needed to evaluate the costs of the two techniques and the appropriate concentrations and volumes of LA for subfascial administration.”