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C-Section 2014

Intra-Operative

Anaesthesia and Analgesia

Anaesthetic Techniques

C-SECTION-SPECIFIC EVIDENCE

  • Three studies comparing CSEA with EA showed a significant reduction in pain scores with CSEA during or after surgery but the results related to the time to first analgesic request were inconsistent Davies et al 1997Click here for more information[/scroll_to]
  • A systematic review comparing the efficacy and side effects of SpA and EA showed no differences in unplanned interventions for pain relief postoperatively. However, there was an increased need for treatment for hypotension in women undergoing SpA Ng et al 2004
  • A systematic review comparing the effects of regional anaesthesia with those of GA showed (based upon one RCT) that the time to first request for analgesia was longer with EA compared with GA. There were no significant differences in the Apgar scores at 1, 5 and 10 min Afolabi and Lesi 2012
  • CSEA with epidural volume extension (EVE) was not superior to SpA in reducing intraoperative pain scores and the time to first analgesic request Lew et al 2004
  • One study showed a significant reduction in the time to first analgesic request for the SpA group compared with the CSEA group. However, there was no significant difference in supplemental analgesic use Thorén et al 1994
  • Two studies comparing EA with SpA showed inconsistent results related to pain scores and the need for supplemental analgesic use Paraskeva et al 2012  Click here for more information
  • Combined spinal-epidural anaesthesia (CSEA) vs epidural anaesthesia (EA) or spinal anaesthesia (SpA) study details Click here for more information
  • EA vs SpA study details Click here for more information
  • EA or SpA versus general anaesthesia (GA) study details Click here for more information
  • CSEA vs EA or SpA
  • EA vs SpA
  • EA or SpA vs GA

Intrathecal (IT) or Epidural Analgesia

C-SECTION-SPECIFIC EVIDENCE: IT ANALGESIA CONTINUED AFTER ANAESTHESIA

  • 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
  • IT opioid versus LA wound infiltration or placebo study details Click here for more information
  • IT opioid vs epidural opioid study details Click here for more information
  • IT opioid vs LA wound infiltration or placebo
  • IT opioid vs epidural opioid
  • The administration of PCEA pethidine compared with IT morphine during surgery plus IV pethidine via PCA or IT morphine during surgery plus postoperative oral paracetamol and codeine produced similar pain relief at most time points. Patients receiving epidural pethidine had a trend towards higher pain scores but also lower nausea and pruritus scores Paech et al 2000

Neuraxial Clonidine

C-SECTION-SPECIFIC EVIDENCE

  • The comparison of three doses of IT clonidine (150 µg, 300 µg and 450 µg) demonstrated a dose-dependent effect. A higher dose was significantly associated with lower pain scores and a delayed request for supplemental analgesics Filos et al 1994
  • Epidural infusion of clonidine (400 µg bolus plus 10 µg/h) and (800 µg bolus plus 20 µg/h) compared with placebo prolonged the time to first analgesic request. Only the high-dose clonidine group needed less morphine via iPCA compared with the placebo group Mendez et al 1990
  • Analgesia with bupivacaine (0.06 mg/cm body height) plus clonidine (75 µg) or plus clonidine and fentanyl (12.5 µg) was superior to bupivacaine alone. Time to first analgesic request was significantly prolonged following anaesthesia with bupivacaine, clonidine and fentanyl compared with the other groups. Intraoperative nausea-vomiting was more frequent in the group given bupivacaine alone  Benhamou et al 1998The administration of IT clonidine 150 µg was superior to placebo in terms of postoperative pain relief and time to first analgesic request. However, the side effects sedation, hypotension and dryness of mouth were more frequent in the clonidine group Filos et al 1992
  • Spinal bupivacaine combined with sufentanil 2 µg and 75 µg clonidine was superior to sufentanil 2 µg alone and 150 µg clonidine alone in the time to first analgesic request. However, there was no significant difference among the three groups in postoperative pain scores and in the need for supplemental analgesia Lavand’homme et al 2008
  • Spinal anaesthesia with a combination of subarachnoid morphine100 µg and clonidine at different doses compared with subarachnoid morphine100 µg alone or clonidine 150 µg alone significantly improves postoperative pain relief, but increases intraoperative sedation Paech et al 2004
  • Spinal bupivacaine plus clonidine 75 µg was superior in terms of duration of postoperative analgesia compared with spinal bupivacaine plus fentanyl 25 µg without any increase in maternal side effects Singh et al 2013
  • Spinal anaesthesia with bupivacaine 0.5% (2.2 mL) plus clonidine 75 µg was superior to bupivacaine 0.5% (2.2 mL) alone in time to first analgesic request and pain score at 1h, but not on 24h, without significant maternal and neonatal side-effects van Tuijl et al 2006
  • Neuraxial clonidine study details Click here for more information

Operative techniques

Surgical Techniques

C-SECTION-SPECIFIC EVIDENCE

  • Joel-Cohen-based compared with Pfannenstiel caesarean section techniques were associated with lower duration of postoperative pain and with less use of analgesia Hofmeyr et al 2008
  • The Joel-Cohen incision was significantly superior to the Pfannenstiel incision for operative time, postoperative pain, postoperative need for supplemental analgesia, time to get out from bed and time to walk straight without support Abuelghar et al 2013
  • A systematic review of RCTs comparing different abdominal incisions showed that the Joel-Cohen incision was superior to the Pfannenstiel approach in reducing postoperative analgesic requirements, total dose of analgesia in the first 24 h and in increasing the time to first analgesic request Mathai et al 2013
  • A systematic review showed that there is little information available to inform the choice of the most appropriate surgical technique for uterine incision and uterine closure to adopt Dodd et al 2008
  • Surgical techniques study details Click here for more information

Non-closure versus Closure

C-SECTION-SPECIFIC EVIDENCE

  • A systematic review evaluating the effects of non-closure as an alternative to closure of the peritoneum showed that the number of postoperative analgesic doses was reduced in the peritoneal non-closure group Bamigboye and Hofmeyr 2003 Non-closure of both the visceral and the parietal peritoneum produced a significant reduction in pain scores and need for supplemental analgesia compared with closure Tabasi et al 2013
  • Non-closure and closure of the parietal peritoneum showed no differences in duration of surgery and postoperative pain scores. However, the non-closure group had a significantly reduced requirement for supplemental analgesia as well as shorter time to mobilisation and oral intake Altinbas et al 2013
  • Parietal peritoneal non-closure was associated with significantly lower pain scores and morphine consumption compared with closure Shahin et al 2009
  • Non-closure versus closure study details Click here for more information

 

Techniques and Materials for Skin Closure

C-SECTION-SPECIFIC EVIDENCE

  • A systematic review assessing different effects of skin closure techniques and materials showed no conclusive evidence about how the skin should be closed after caesarean section  Mackeen et al 2012
  • Techniques and materials for skin closure study details Click here for more information

  • CSEA was superior to EA in pain relief during delivery but not in postoperative pain scores. There was no difference in postoperative meperidine consumption and maternal satisfaction score (Davies 1997, N=114, LoE 1)
  • Significantly more women receiving EA reported intraoperative pain, but women with CSEA felt earlier postoperative pain (Karaman 2005, N=80, LoE 1)
  • Patients receiving CSEA had consistently lower postoperative pain scores, but the difference was only significant at 24 h postoperatively. Women in the EA group requested additional analgesics significantly earlier (Norman 1998, N=56, LoE 1)

  • EA was superior to SpA in reducing postoperative supplementary analgesics. However, there were no significant differences in pain scores at any measurement up to 24 h (Paraskeva 2012, N=99, LoE 1)
  • Women with EA had higher pain scores during the first 24 h and needed a significantly higher overall dosage of rectal diclofenac (Schewe 2009, N=125, LoE 2)

reference participants’ characteristics intervention group/ control group

 

 outcomes critical appraisal/ conclusion
Davies 1997

Maternal experience during epidural or combined spinal-epidural anaesthesia for caesarean section: A prospective randomized trial

 

Anesthesia and Analgesia, 1997. 85(3): p. 607-613.

 

 inclusion criteria

– healthy parturients

– cephalic fetus

exclusion criteria

– cardiovascular disease

– preeclampsia

– placenta previa

– uterine contractions

demographic data

no significant differences in baseline characteristics

maternal age [yr]: mean ± SD

CSEA: 29 ± 7

EA: 28 ± 10

weight [kg]: mean ± SD
CSEA: 80 ± 17

EA: 75 ± 27

nulliparity [n (%)]

CSEA: 14 (24)

EA: 14 (26)

previous caesarean section [n (%)]

CSEA: 40 (68)

EA: 38 (69)

patient flow and follow up

total patient number included:

120

randomised in:

CSEA :60

EA: 60

excluded:

CSEA:

– 1 for incomplete data

EA:

– 3 for incomplete data

– 2 for failed block

analysed:

CSEA: 59

EA: 55

follow up:

24 hours

 

 

 premedication

– ranitidine 150 mg PO the night before and the morning of surgery

prior to anaesthesia

– metoclopramide 10 mg

– 10 mL/kg of warmed crystalloid IV

– prophylactic ephedrine infusion (30 mg in 500 mL normal saline)

intervention and control group

CSEA group

– hyperbaric 0.5% bupivacaine 2.5 mL with fentanyl 10 µg in 0.2 mL (total 2.5 mL) IT

– 3 mL of 2% lidocaine with epinephrine 1: 200,000 epidural

EA group

– 20 mL 2% lidocaine with epinephrine 1: 200,000

– 2 mL 8.4% sodium bicarbonate

– 2 mL fentanyl 50 µg/mL (total 24 mL) was prepared. A 3 mL test dose was followed by 12 mL incrementally over a 10-min period. Further doses permitted 15 min after initial injection.

surgical approach
not reported.

intraoperative pain management

– bolus of synthetic oxytocin 5-10 U was followed by an infusion at approx. 4 U/h

– supplementary epidural drugs or opioid IV were permitted at any time during surgery.

postoperative pain management

epidural meperidine (50 mg bolus doses administered by a nurse every 2 h as needed)

 

 

 intraoperative pain score [VAS]

CSEA significantly reduced:

– block insertion (p=0.02)
– during delivery (p=0.01)

no significant differences between the two groups:

– skin insertion

– peritoneal closure

– global intraoperative pain score

women reporting zero pain scores [%]:

EA: 44

CSEA: 63

(p=0.09)

additional intraoperative analgesics (epidural opioid or local anaesthetic, IV opioid) [%]:
EA: 42

CSEA: 27

(p=0.12)

intraoperative epidural or IV opioid [%]:

EA: 13

CSEA: 7
(p=0.36)

maternal pain 24 hour score [VAS]

no significant differences between the groups

meperidine consumption

no significant differences between the groups

APGAR-Score

no significant differences between the groups

anxiety and satisfaction scores  24 hours postpartum

no significant differences between the groups.

adverse effects/ events:

no significant differences in:

– nausea

– vomiting

– shivering

– incidence of headache or postural headache.

backache at some stage during the first 3 postpartum days [%]:

EA: 55

CSEA: 62

(p=0.45)

 

 methodological shortcomings

– allocation concealment not reported

– no sample size calculation

– selective outcome reporting unclear

level of evidence: 1

authors’ conclusion

“Both EA and CSEA have low failure rates, provide good operative conditions, and confer high levels of maternal satisfaction. Maternal advantages with CSEA include greater satisfaction after block placement before surgery and reduced pain during delivery of the fetus. Increased ephedrine requirements with CSEA are unlikely to be of clinical importance.”
Karaman 2005

Comparison of the maternal and neonatal effects of epidural block and of combined spinal-epidural block of Cesarean section

 

European Journal of Obstetrics Gynecology and Reproductive Biology, 2005. 121(1): p. 18-23.

 inclusion criteria

– ASA status I-II

– 18 to 40 year-old

– unpremedicated

– uncomplicated singleton pregnancies

– wished to be conscious during surgery

exclusion criteria

– twins pregnancy

– placenta previa

– pregnancy- induced hypertension

demographic data

no significant differences in baseline characteristics

age [yr.]: mean ± SD

CSEA: 28.9 ± 3.32

EA: 30.4 ± 4.94

BMI [kg/m²]: mean ± SD

CSEA: 28.15 ± 4.72

EA: 28.4 ± 5.31

para 0 [n (%)]

CSEA: 16 (40)

EA: 14 (35)

previous caesarean section [n (%)]

CSEA: 20 (50)

EA: 22 (55)

patient flow and follow up

total patient number included:

80

randomised in:

CSEA: 40

EA: 40

excluded:

0

analysed:

80

follow up:
3 days

 prior to anaesthesia
– metoclopramide 10 mg- 10 mL/kg warmed (37°C) Ringer lactate solution IV- Oxygen 6 L/minintervention and control groupCSEA group-1.5–1.8 mL 0.5% hyperbaric bupivacaine IT (volume varying with patient’s height, infusion over 30 s)- if block does not reach T4 after 10 min: additional 10 mL 0.25% plain bupivacaine and 50 µg fentanyl (top-up) epiduralEA group– 3 mL 2% lidocaine as test dose- 14–16 mL 0.5% bupivacaine and 100 µg fentanyl- until a sensory block extended to T4 additional 2 mL 0.5% bupivacaine was givensurgical approachnot reported.

intraoperative pain management

– fentanyl IV in 50-µg increments if pain VAS>/=40

postoperative pain management

– epidural morphine if needed in both groups

 intraoperative complete analgesia [VAS=0]

– no women in CSEA group complained of pain or needed fentanyl

– but 3 of 11 woman in EA group who complained of pain required fentanyl

(p=0.001)

onset of postoperative pain [min]: mean ± SD

CSEA: 167 ± 42.4

EA: 210 ± 37.2

(p<0.01)

APGAR-Score

no significant differences between the groups

morphine consumption

not reported

adverse effects/ events:

no significant differences between the groups:
– hypotension
– nausea
– vomiting
– none developed postdural puncture headaches

shivering [n (%)]
CSEA: 2 (5)
EA: 14 (35)
(p=0.001)

 

 methodological shortcomings

– allocation concealment not reported

– no blinding of participants and personnel

– no sample size calculation

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“CSEA, in which spinal anesthesia is combined with a lower dose of bupivacaine and supporting epidural top-up with 0.25% bupivacaine, has greater efficacy and fewer side effects than EA in Cesarean sections.”
Norman 1998

Analgesia produced by epidural diamorphine is better following cesarean section under spinal anesthesia than under epidural anesthesia

 

International Journal of Obstetric Anesthesia, 1998. 7(2): p. 98-102.

 

 inclusion criteria

– ASA status I–II

– singleton pregnancy of greater than 36 weeks duration

exclusion criteria

– in labour

– had received analgesia in the last 6 h

– contraindications to diclofenac

demographic data

no significant differences in baseline characteristics

age [yr.]: mean ± SD

CSEA: 32 ± 5

EA: 34 ± 6

height [cm]: mean ± SD

CSEA: 163 ± 8

EA: 165 ± 7

weight [kg]: mean ± SD

CSEA: 66.4 ± 14.0

EA: 69.4 ± 13.3

previous caesarean section [n (%)]

CSEA: 15 (42.3)

EA: 11 (46.8)

patient flow and follow up

total patient number included:

70

randomised in:

not reported

excluded: 12

– 2 because epidural space could not be located

– 3 had epidural catheters removed before epidural diamorphine was required

– 1 did not require epidural diamorphine throughout 24 h study period

– 6 patients as their record cards were unavailable

analysed: 56

CSEA: 32
EA: 26

follow up:

24 hours

 prior to anaesthesia

– ranitidine 150 mg PO

– metoclopramide 10 mg PO

– Hartmann’s solution 500 mL IV

intervention and control group

CSEA group

– 2.2 mL of 0.5% hyperbaric bupivacaine IT

– if sensory block incomplete to T4 increments of 0.5% of plain bupivacaine epidural

EA group

– increments of 0.5% plain bupivacaine

surgical approach

not reported

postoperative pain management

all patients:

-100 mg diclofenac rectal

at first request

– 2.5 mg diamorphine made up to 10 mL in 0.9% saline epidural

other given analgesia

– diclofenac 50 mg PO 8-hourly

additional analgesic requirements

– co-dydramol PO (dihydrocodeine tartrate 10 mg, paracetamol 500 mg)

– morphine 10 mg IM

 intraoperative analgesia requirements [n (%)]:

CSEA:11 (34.4)

EA: 9 (34.6)

median postoperative pain score

consistently lower in CSEA but only significant difference at 24h (p=0.021)

onset of block for surgery and postoperative administration of epidural diamorphine: mean time [h] ± SD

CSEA: 4.1 ± 2.2

EA: 5.3 ± 2.2

(p=0.016)

requirement of postoperative morphine IM [n/%]

CSEA: 11 (34.4)

EA: 9 (34.6)

(p=NS)

time to administration of morphine IM: [h] ± SD

CSEA: 12.6 ± 5.9

EA: 6.6 ± 3.1

(p=0.01)

adverse effects/ events:

no significant differences between the groups:
– sedation score = 2 (heavily sedated)
– nausea
– vomiting
– itching

 methodological shortcomings:

– allocation concealment not reported

– selective outcome reporting unclear

level of evidence: 1

authors’ conclusion

“In conclusion, epidural diamorphine 2.5 mg produced better analgesia after combined epidural-spinal anaesthesia than after epidural anaesthesia for caesarean section. Regular administration of diclofenac and availability of co-dydramol may have reduced the requirement for stronger analgesia, although this was not addressed by our study design.”
Lew 2004

Combined spinal-epidural anesthesia using epidural volume extension leads to faster motor recovery after elective cesarean delivery: A prospective, randomized, double-blind study

 

Anesthesia and Analgesia, 2004. 98(3): p. 810-814.

 

 inclusion criteria

– ASA status I–II

– body weight 50–95 kg

– height 150–170 cm

– singleton pregnancy

exclusion criteria

– contraindications to regional anaesthesia

– emergent caesarean deliveries

– hypertensive disorders

– peripartum haemorrhagic conditions

demographic data

no significant differences in baseline characteristics

age [yr.]: mean ± SD

SpA: 33 ± 5

CSEA 2: 32 ± 5

height [cm]: mean ± SD

SpA: 157 ± 6

CSEA: 158 ± 4

weight [kg]: mean ± SD

SpA: 69 ± 11

CSEA: 69 ± 10

patient flow and follow up

total patient number included:

62

randomised in:

SpA: 31

CSEA: 31

excluded:

0

analysed:

62

follow up:
24 hours

 prior to anaesthesia

– ranitidine PO

– sodium citrate PO

intervention and control group

SpA group

– 9.0 mg of hyperbaric 0.5% bupivacaine

– fentanyl 10 µg IT over 10 s without barbotage

CSEA group

– 5.0 mg of hyperbaric 0.5% bupivacaine

– fentanyl 10 µg IT over 10 s without barbotage

– 5 min from completion of IT injection: 6.0 mL of 0.9% saline over 30 s epidurally

surgical approach

not reported.

intraoperative pain management

CSEA group:
– If VAS >30 epidural boluses of 3 mL of 1.5% lidocaine

both groups:

– IV adjuncts such as fentanyl 25 µg and ketorolac 30 mg after delivery

postoperative pain management

meperidine IM

 

 modified Bromage score

significantly lower in patients of the CSEA group

(p<0.05)

intraoperative pain

no significant differences between the groups

first request for postoperative analgesia
no significant differences between the groups

APGAR-Score

no significant differences between the groups

adverse effects/ events:

no significant differences in:
– nausea
– vomiting
– pruritus
– shivering
– postspinal headache

 

 

 methodological shortcomings:

– allocation concealment not reported

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“The study shows that CSEA with epidural volume extension (EVE provided adequate anesthesia for elective cesarean delivery with only 55% of the bupivacaine dose and allows a more rapid motor recovery of the lower limbs, which may have an impact on shortening PACU stay. Moreover, the use of saline for epidural boluses is economical. With modification, the epidural catheter could be retained to provide postoperative analgesia. These data suggest that CSEA with EVE should be considered a novel alternative to spinal anesthesia for cesarean delivery”
Thorén 1994

Sequential combined spinal epidural block versus spinal block for cesarean section: effects on maternal hypotension and neurobehavioral function of the newborn

 

Anesthesia and Analgesia, 1994. 78(6): p. 1087-1092.

 

 inclusion criteria

– ASA physical status I

– full-term pregnancy

– unpremedicated

– wished to be awake during surgery

– uncomplicated, singleton pregnancies

exclusion criteria

not reported.

demographic data

no significant differences in baseline characteristics

age [yr.]: mean ± SD

SpA: 28.8 ± 0.9

CSEA: 31.1 ± 1.0

height [cm]:mean ± SD

SpA: 164.0 ± 1.6

CSEA: 166.1 ± 1.3

weight [kg];mean ± SD

SpA: 75.9 ± 2.2

CSEA: 75.1 ± 2.4

gestation age [weeks] ± SD

SpA: 38.7 ± 0.1

CSEA:38.6 ± 0.1

patient flow and follow up

total patient number included:

42

randomised in:

SpA: 21
CSEA: 21

excluded: 1

not reported.

analysed: 41

SpA: 20

CSEA: 21

Follow up:

24 hours

 prior to anaesthesia

– 1500–2000 mL acetated Ringer´s solution

intervention and control group

SpA

– hyperbaric bupivacaine 0.5% 12.5 mg in 8% glucose IT

CSEA

– hyperbaric bupivacaine 0.5% (1.5 mL; 7.5 mg) IT

– if T4 level is not reached after 15 min additional bupivacaine was injected epidurally: after a test dose (2 mL 0.5%) an additional 2 mL per unblocked segment was given until T4 level was achieved

intraoperative pain management

– fentanyl 50-µg-increments IV

surgical approach

not reported.

postoperative pain management

– ketobemidone IM

 supplementary dose to obtain a T4 sensory block

all patients in the CSEA group needed supplementary epidural bupivacaine.

intraoperativesupplementary drugs
no supplementary drugs were needed.

postoperative drug requirement

no difference between groups in the need for fentanyl and/ or dixyrazine.

time between induction of block and first request of postoperative pain relief [min] ± SD

CSEA: 208 ± 18.2

SpA: 151 ± 21.7

(p<0.05)

total dose of ketobemidone [mg] ± SD

no differences between the groups.

CSEA: 23.7 ± 1.5

SpA: 22.1 ± 1.7

(p=NS)

APGAR Scores
similar in both groups.

adverse effects/ events

no postdural puncture headache

 methodological shortcomings

– generation of sequence generation unclear

– allocation concealment not reported

– blinding of participants, personnel unclear

– selective outcome reporting

– no sample size calculation

level of evidence: 2

authors’ conclusion

“In conclusion, the sequential CSEA technique proved to be as safe and as effective as spinal anesthesia for cesarean section. There is a risk of hypotension with both techniques, although it is more precipitous after conventional spinal block. Provided that hypotension is aggressively treated, neonatal outcome is good after both anesthetic techniques. With the CSEA technique, the presence of an epidural catheter provides a capability to extend or prolong an inadequate spinal block. The sequential CSEA technique may be particularly advantageous in high-risk parturients.“

 

reference Participants” characteristics intervention group/ control group

 

 outcomes critical appraisal/ conclusion
Ng 2004

Spinal versus epidural anaesthesia for caesarean section.

 

Cochrane Database Syst Rev, 2004(2): p. Cd003765.

 databases/ search engines

– Cochrane Pregnancy and Childbirth Group’s Trials Register

– Central

– Pubmed/ Medline

– hand searches of 30 journals and proceedings of major conferences

search period

through February 2003

inclusion criteria

– randomised controlled trials

– comparing SpA with EA

exclusion criteria

– cluster-randomised trials and trials using cross-over design

– combined spinal-epidural techniques

included studies (n participants)

[1] Alahuhta 1990 (55)

[2] Erbay 2001 (60)

[3] Helbo-Hansen 1988 (40)

[4] Jani 1989 (41)

[5] Ledan 1993 (20)

[6] Lertakyamanee 1999 (238)

[7] Mahajan 1992 (99)

[8] Olofsson 1997 (100)

[9] Saito 1998 (31)

[10] Vegfors 1992 (100)

 [1] Alahuhta 1990

SpA: 2.5 mL of 0.5% bupivacaine containing 8% glucose injected via a 25 G needle at L3-4 in the sitting position

EA: 0.5% bupivacaine, 2 mL test dose followed by 14–20 mL main dose via epidural catheter inserted with 18 G Tuohy needle in the left lateral position. Bupivacaine added until analgesia reached T4-5

[2] Erbay 2001

SpA: 2.5 mL of 0.5% hyperbaric bupivacaine

EA: 10 mL of 0.5% hyperbaric bupivacaine

[3] Helbo-Hansen 1988

SpA: 2.6 mL plain bupivacaine 0.5% injected in left lateral position through 26 gauge spinal

needle at L3-4 interspace

EA: epidural catheter via Tuohy needle at L2-3 interspace, inserted in sitting position, test dose of 3 mL 0.5% bupivacaine, followed by initial dose of 10 mL injected 5 minutes later, then placed in the left lateral position after another 5 minutes, further boluses of 0.5% bupivacaine were given until anaesthetic level had reached T6 bilaterally.

[4] Jani 1989

SpA: 0.5% plain bupivacaine (median dose 0.14 mg/kg)

EA: incremental doses of plain 0.5% bupivacaine (median dose 1.7 mg/kg)

[5] Ledan 1993

SpA: 24 gauge Sprotte needle inserted at L2-3. 0.08 mg/cm of 0.5% hyperbaric bupivacaine

injected in 30 sec.

EA: 17 G Tuohy needle inserted in sitting position at L2-3. 10 mL 0.5% plain bupivacaine injected followed 5 minutes later by 20 mL/h infusion until T6 level achieved

[6] Lertakyamanee 1999

SpA: 25 G spinal needle inserted at L3-4. 1.2 mL 5% lignocaine injected

EA: Tuohy needle at L3-4. 18–20 mL of 2% lignocaine with adrenaline 1:200,000

[7] Mahajan 1992

SpA: 22–24 gauge needle inserted in the lateral position at L2-3 or L3-4. 1.2–1.5 mL of 1% bupivacaine injected slowly

EA: Tuohy needle, lateral position, L2-3 or L3-4, loss of resistance to air, 12–20 mL 0.5% bupivacaine injected slowly

[8] Olofsson 1997

SpA: at the L3-4 interspace, inserted in the sitting position. 2.5 mL 0.5% hyperbaric bupivacaine injected with or without 10 mcg fentanyl

EA: 18 G Tuohy needle inserted at the L3-4 interspace in the left lateral position, an epidural

catheter was threaded 3 cm into epidural space. 20 mL 0.5% bupivacaine with or without 100 mcg fentanyl was injected via the catheter into the epidural space

[9] Saito 1998

SpA: 25 G needle inserted in the lateral position at L4-5, 2mL hyperbaric 5% dibucaine injected

EA: 17 G Tuohy needle inserted in the lateral position with the paramedian approach at L2-3 using loss of resistance to air. 20 mL 2% mepivacaine subsequently injected as a bolus

[10] Vegfors 1992

SpA: 2.5 mL of bupivacaine 5 mg/mL in 8% glucose, performed in the sitting position with a 25 gauge Quincke needle

EA: epidural catheter inserted with women in the lateral position through a 17 gauge needle, mepivacaine 20 mg/mL with adrenaline 5 mg/mL injected via catheter, test dose of 5 mL first, followed 5 minutes later by main dose of 17 mL as a bolus injection. 5 mL supplements given if desired level of anaesthesia not reached after 30 min

 

 time for surgery to commence [min]: MD (95% CI)

shorter in women undergoing SpA: -7.91 (-11.59,-4.23) [1,2,5,6]

failure to achieve adequate anaesthesia to begin surgery: risk ratio (95% CI)

no differences between SpA and EA: 0.98 (0.23;4.24) [1,3,6,9]

need for additional pain relief during surgery: risk ratio (95% CI)

no differences between SpA and EA: 0.88 (0.59;1.32) [1,5,8,6,10]

need for treatment for hypotension: risk ratio (95% CI)

increased need for treatment in women undergoing SpA: 1.23 (1.00;1.51) [1,5,7,6,9,10]

women unsatisfied with anaesthetic: risk ratio (95% CI)

no differences between SpA and EA: 1.00 (0.71;1.41) [5,6]

maternal satisfaction: MD (95% CI)

no differences between SpA and EA: -0.34 (-0.98;0.30) [5,6]

need for unplanned pain relief: risk ratio (95% CI)

no differences between SpA and EA: 1.55 (0.67;3.59) [3,5]

 

 methodological shortcomings

– publication bias not assessed

level of evidence: 1

authors’ conclusion

“Both spinal and epidural techniques are shown to provide effective anesthesia for caesarean section. Both techniques are associated with moderate degrees of maternal satisfaction. Spinal anesthesia has a shorter onset time, but treatment for hypotension is more likely if spinal anesthesia is used. No conclusions can be drawn about intraoperative side-effects and postoperative complications because they were of low incidence and/or not reported.”

 
Paraskeva 2012

Postoperative analgesic requirements after subarachnoid or epidural anesthesia with ropivacaine 0.75% in cesarean section. A double-blind randomized trial

 

Current Medical Research and Opinion, 2012. 28(9): p. 1497-1504.

 

 inclusion criteria

– ASA status I–II

– singleton term fetus more than 36 weeks` gestation

exclusion criteria

– physical status ASA > II

– body weight > 20 kg compared to that before pregnancy

– height <157 cm or >175 cm

– pre-eclampsia or eclampsia
– arterial hypertension
– diabetes
– emergency for caesarean section

demographic data

no significant differences in baseline characteristics

age [yr.]: mean ± SD

SpA: 32 ± 4.7

EA: 31 ± 4.2

height [cm]: mean ± SD

SpA: 164 ± 4.5

EA: 165 ± 4.2

weight [kg]:mean ± SD

SpA: 75 ± 8.9

EA: 76 ± 8.8

patient flow and follow up

total patient number included:

108

randomised in:

SpA: 54
EA: 54

excluded: 9

EA:

– 2 failure of block

– 1 inadequate anaesthesia

– 1 broken PCA device

– 2 no relief with PCA

SpA:

– 1 failure to block

– 1 inadequate anaesthesia

– 1 accidental removal of epidural catheter

analysed: 99

SpA:

– 51 included in analyses of morphine consumption

EA:

– 48 included in analyses of morphine consumption

follow up:

24 hours

 prior to anaesthesia

– metoclopramide 10 mg IV

– ranitidine 50 mg IV

– colloid solution 500 mL (Hetastarch 6%)

intervention and control group

SpA
– 2 mL of ropivacaine 0.75% within 15 seconds without barbotage IT

EA

– test dose of 3 mL of lidocaine 2%

– 6 mL of ropivacaine 0.75% epidurally, 5 min apart, followed by a 3 mL dose

supplementary dose to obtain a T4 sensory block

– 6 mL ropivacaine 0.75% epidural

surgical approach

not reported.

intraoperative pain management

– 6 mL ropivacaine 0.75% epidural

postoperative pain management

– 10 mL ropivacaine 0.2% epidural 2, 8 and 24 h after surgery

– PCA 60 mL morphine 1 mg/mL and lock out time of 7 min for IV morphine on demand

 preoperative supplementary dose

supplementary dose to obtain T4 sensory block [n/N]

SpA: 0/52

EA: 11/51

(p=0.001)

intraoperative pain management [n/N]

requirement for rescue dose ropivacaine epidural

SpA: 8/51

EA: 9/52

(p=0.72)

postoperative cumulative morphine consumption at 24h

overall cumulative morphine consumption is significantly lower in EA

(p=0.008)

pairwise comparison

– at 2h and 4 h postoperative significantly lower in EA
(p=0.001)

– no significance at 8h (p=0.14) and 24h (p=0.38)

postoperative VAS at rest and after cough

– no differences between groups

adverse effects/ events

no significant differences between the groups:

– headache

– nausea

– vomiting

satisfaction at 24 h after operation

no differences between groups

(p=0.61)

 

 methodological shortcomings

– generation of allocation sequence unclear

– unclear if blinding of personnel is adequate

level of evidence: 1

authors’ conclusion

“Although subarachnoid anesthesia is usually the regional technique of choice in cesarean section, epidural anesthesia is preferable when cesarean section is necessary and an epidural catheter is already in place for labor analgesia. The findings of the present study design, showed that subarachnoid anesthesia provides a faster onset and faster recovery of the block, but the two techniques do not differ in postoperative analgesic requirements, patient satisfaction or undesirable effects.“
Schewe 2009

Effects of spinal anaesthesia versus epidural anaesthesia for cesarean section on postoperative analgesic consumption and postoperative pain

 

European Journal of Anaesthesiology, 2009. 26(1): p. 52-59.

 inclusion criteria

– ASA status I or II

– full term pregnancy

– wished to receive regional anaesthesia

– uncomplicated pregnancies

exclusion criteria

– age < 18 years

– history of allergy to local anaesthetics

– bleeding tendency

– unable to grasp the concept of PCEA

demographic data

no significant differences in baseline characteristics

age [yr.]: mean ± SD

SpA: 32 ± 5

EA: 33 ± 5

height [cm]:mean ± SD

SpA: 168 ± 6

EA: 168 ± 6

weight [kg]:mean ± SD

SpA: 81 ± 16

EA: 82 ± 14

gestation age [weeks]:mean ± SD

SpA: 37± 2

EA: 37± 2

parity: median (IQR)

SpA: 1 (0–1)

EA 0 (0–1)

Number of patients with previous experience of any type of central neuroaxial block [n (%)]

SpA: 23 (37.1)

EA: 11 (17.5)

(P=0.014)

patient flow and follow up

total patient number included:

132
randomised in: 
SpA: 66
EA: 66

excluded: 7
SpA:
-1 due to unsuccessful attempt of dural puncture
– 1 patient with incorrect PCEA pump use
– 2 patients because PCEA pump failed

EA:

– 2 with unilateral block eventually receiving spinal anaesthesia

– 1 because of PCEA pump failure

analysed: 125

SpA: 62

EA: 63

follow up:

24 hours

 prior to anaesthesia

– 500 mL hydroxyethyl-starch

intervention and control group

SpA

– isobaric bupivacaine 0.5% (0.5 mg per 10 cm height) and 5 µg sufentanil IT without barbotage over 30s

EA

– epidural test dose of 12.5 mg isobaric bupivacaine 0.5%

– ropivacaine 0.75% (7.5 mg per 10 cm height)

– 10 µg sufentanil epidural

surgical approach

Misgav-Ladach technique

postoperative pain management

– PCEA (bolus of ropivacaine  0.133% with lock-out period of 1 h according to patients´ height

– if inadequate analgesia:

100 mg diclofenac rectal

 

 intraoperative pain [VAS score]: Median (IQR)

SpA: 0 (0–0)

EA: 0 (0–14)

(p=0.001)

intraoperative supplementary dose

no patient needed additional IV analgesia.

analgesic consumption

24 h PCEA ropivacaine consumption [mg] ± SD

SpA: 136 ± 63

EA: 157 ± 82

(p=0.12)

diclofenac [n/N]

SpA: 39/62

EA: 53/63

(p=0.007)

dosage of supplementary analgesia [mg]: mean ± SD

SpA: 83 ± 81

EA: 124 ± 78

(p=0.005)

postoperative pain at rest and on coughing

comparable between both groups only immediately and 3h after surgery, at all other time points up to 24h, women with EA had higher pain scores (p<0.05)

adverse effects/ events

pruritus [n/N]
SpA: 57/62

EA: 40/63
(p=0.0001)

vertigo [n/N]
SpA: 6/62

EA: 20/63
(p=0.0024)

backache [n/N]
SpA: 32/62

EA: 44 /63
(p=0.037)

no significant differences between the groups in:

– nausea

– vomiting

– headache

– sedation score >1

– hypotension (systolic blood pressure <80 mmHg)

– vasoconstrictive medication

 

 

 methodological shortcomings

– generation of sequence generation unclear

– allocation concealment not reported

level of evidence: 2

authors’ conclusion

“In parturients undergoing elective caesarean section, postoperative use of epidural ropivacaine via patient-controlled epidural analgesia is similar after spinal and epidural anaesthesia. Spinal anaesthesia is, however, accompanied with less postoperative pain, use of additional analgesics and side-effects.”

 

reference participants” characteristics intervention group/ control group

 

 outcomes critical appraisal/ conclusion
Afolabi 2012

Regional versus general anaesthesia for caesarean section.

 

Cochrane database of systematic reviews (Online), 2012. 10: p. CD004350.

 databases/ search engines

– Cochrane Pregnancy and Childbirth Group’s Trials Register

– Central

– Pubmed/ Medline

– Embase

– hand searches of 30 journals and proceedings of major conferences

search period

through 20th August 2012

inclusion criteria

– randomised and quasi-randomised controlled trials

– comparing effects of RA with those of GA

– elective or emergency caesarean section for any indication

exclusion criteria

– cluster-randomised trials and trials using cross-over design

 

included studies (n participants)

[1] Akyol 2006 (62)

[2] Bengi Sener 2003 (30)

[3] Braithwaite 1993 (50)

[4] Datta 1983 (30)

[5] Dermitzaki 2009 (25)

[6] Dick 1992 (47)

[7] Dogan 2008 (40)

[8] Dyer 2003 (70)

[9] Hodgkinson 1980 (20)

[10] Hollmen 1978 (30)

[11] Hong 2002 (25)

[12] Jain 2009 (40)

[13] Kavak 2001 (84)

[14] Kim 2000 (30)

[15] Korkmaz 2004 (30)

[16] Lertakyamanee 1999 (341)

[17] Mahajan 1992 (90)

[18] Mancuso 2010 (179)

[19] Mathur 2002 (60)

[20] Momani 2001 (45)

[21] Moslemi 2007 (60)

[22] Nabhan 2009 (82)

[23] Papadopoulou 2005 (32)

[24] Pence 2002 (56)

[25] Petropoulos 2003 (230)

[26] Turhanoglu 1999 (60)

[27] Wallace 1995 (80)

[28] Yegin 2003 (62)

[29] Yentur 2009 (70)

 

 

 [1] Akyol 2006

SpA: bupivacaine

GA: thiopental, rocuronium, and a mixture of nitrous oxide and oxygen and sevoflurane

[2] Bengi Sener 2003

EA: bupivacaine

GA: thiopental, succinyl choline, mixture of nitrous oxide and oxygen, isoflurane and vecuronium

[3] Braithwaite 1993

SpA: heavy bupivacaine

GA: thiopental, suxamethonium chloride, mixture of nitrous oxide and oxygen, halothane and droperidol and fentanyl

[4] Datta 1983

Two types of regional anaesthesia used:

SpA: 0.5% tetracaine

GA: thiopental with 50% nitrous oxide in oxygen

[5] Dermitzaki 2009

CSEA: levobupivacaine

and fentanyl +/- levobupivacaine respectively

GA: thiopentone, succinylcholine, nitrous oxide/oxygen and sevoflurane, and vecuronium

[6] Dick 1992

EA: 12–15 mL of bupivacaine

GA: thiopentone, succinylcholine, nitrous oxide/oxygen and halothane

[7] Dogan 2008

CSEA: bupivacaine

GA: thiopental sodium, atracurium, nitrous oxide/oxygen and sevoflurane

[8] Dyer 2003

SpA: 1.8 mL hyperbaric bupivacaine 0.5% with 10 µg fentanyl

GA: thiopentone, suxamethonium, nitrous oxide/oxygen, isoflurane and magnesium sulphate

[9] Hodgkinson 1980

EA: 12-20 mL of bupivacaine 0.75%

GA: thiopentone, succinyl choline, nitrous oxide and halothane

[10] Hollmen 1978

EA: lidocaine and epinephrine

GA: thiopentone, 1:1 mixture of nitrous oxide and oxygen, and succinyl choline

[11] Hong 2002

EA: lidocaine (20 mL of 2%), plus epinephrine (1:200,000) and morphine (2 mg in 4 mL)

GA: thiopentone, succinyl choline, vecuronium, mixture of nitrous oxide and oxygen and enflurane

[12] Jain 2009

SpA: heavy bupivacaine with 25 µg fentanyl

GA: thiopentone and suxamethonium.

[13] Kavak 2001

SpA: 12.5 mg of 0.5% heavy bupivacaine and morphine

GA: thiopental sodium, succinyl choline, mixture of nitrous oxide and oxygen, sevoflurane and vecuronium

[14] Kim 2000

EA: bupivacaine

GA: sodium thiopental, succinyl choline, enflurane, mixture of nitrous oxide and oxygen, midazolam and vencuronium

[15] Korkmaz 2004

CSEA: 5 mg of 0.5% bupivacaine and fentanyl, with additional ropivacaine top-ups if necessary

GA: sevoflurane

[16] Lertakyamanee 1999

SPA: 5% lidocaine

EA: 2% lidocaine

GA: halothane, a mixture of nitrous oxide and oxygen and pancuronium bromide

[17] Mahajan 1992

EA: 0.5% bupivacaine

SpA: 1% bupivacaine

GA: thiopentone, suxamethonium, nitrous oxide and oxygen, halothane and pancuronium

[18] Mancuso 2010

SpA: hyperbaric bupivacaine or isobaric levobupivacaine

GA: propofol, cis-atracurium, sevoflurane and mixture of nitrous oxide and oxygen

[19] Mathur 2002

SpA: bupivacaine

EA: 2% lidocaine or bupivacaine

GA: thiopental and succinyl choline, maintained on nitrous

oxide and oxygen

[20] Momani 2001

GA: bupivacaine wound infiltration

GA: without wound infiltration

thiopentone, suxamethonium, halothane and 50% nitrous oxide in oxygen in both GA

SpA: hyperbaric bupivacaine;

bupivacaine also infiltrated into the wound

[21] Moslemi 2007

SpA: hyperbaric bupivacaine and fentanyl

GA: thiopental, succinyl choline, lidocaine, fentanyl, mixture of nitrous oxide and oxygen, halothane and atracurium

[22] Nabhan 2009

SpA: hyperbaric bupivacaine and fentanyl

GA: sodium thiopental, succinyl choline, isoflurane and mixture

of nitrous oxide and oxygen

[23] Papadopoulou 2005

SpA: 10–15 mg bupivacaine

GA: thiopentone and ’Sucin’ with sevoflurane and nitrous oxide 50% in oxygen

[24] Pence 2002

EA: 50 mg bupivacaine and fentanyl

GA: isoflurane with propofol and succinylcholine

[25] Petropoulos 2003

EA: ropivacaine after a test dose of xylocaine

GA: thiopentone, suxamethonium, nitrous oxide and oxygen, sevoflurane and vecuronium

[26] Turhanoglu 1999

SpA: 12.5 mg of 0.5% heavy bupivacaine

GA: propofol, succinyl choline, mixture of nitrous oxide and oxygen and isoflurane, vecuronium added where necessary

[27] Wallace 1995

EA: 2% lidocaine

EA: 3% chloroprocaine

GA: thiopental, succinylcholine, mixture of nitrous oxide and oxygen, isoflurane and atracurium or vecuronium. lidocaine and nitroglycerin administered before intubation to prevent hypertension from tracheal stimulation

[28] Yegin 2003

EA: 15 mL of 0.5% bupivacaine

GA: isoflurane with vecuronium, thiopental and suxamethonium

[29] Yentur 2009

EA: bupivacaine

GA: thiopental, succinyl choline, isoflurane and mixture of nitrous oxide and oxygen and atracurium

 maternal outcomes

maternal deaths

no trial provided data

pre and postoperative haematocrit

EA superior to GA [%]: MD (95% CI)

1.70 (0.47;2.93) [16]

SpA superior to GA [%]: MD (95% CI)

3.10 (1.73,4.47)

maternal blood loss

less in EA compared with GA [mL]: SMD (95% CI)

-0.32 (-0.56;-0.07) [11,16]

less in SpA compared with GA [mL]: SMD (95% CI)

-0.59 (-0.83;-0.35) [8,16]

wound and other infections

no trial provided data

intraoperative pain

less during GA compared with EA: MD (95% CI)

0.84 (0.45;1.23) [16]

less during GA compared with SpA: MD (95% CI)

0.69 (0.32;1.06) [16]

time to first analgesic request

longer with EA compared with GA [min]: MD (95% CI)

500.00 (364.36;635.64) [11]

longer with SpA compared with GA [min]: MD (95% CI)

97.80 (90.28;105.32) [26]

adverse events

no significant differences in

anaphylactic reactions, thromboembolic disease and backache. Headache, epigastric pain, blurred vision, convulsions, pruritus, shivering and bradycardia

neonatal outcomes

neonatal deaths

no trial provided data

Apgar score

no significant differences at 1 min

EA <> GA            [9,16,19,28,29]

SpA <> GA             [16,13,19,1,21]

CSEA <> GA    [15]

no significant differences at 5 min

EA <> GA         [9,16,28,29]

SpA <> GA       [16,13,1,21]

CSEA <> GA    [15]

no significant differences at 10 min

SpA <> GA       [19]

EA <> GA         [19]

need for oxygen for resuscitation

no significant differences

EA <> GA         [25]

CSEA <> GA    [25]

 methodological shortcomings

– publication bias not assessed

level of evidence: 1

authors’ conclusion

“There is no evidence from this review to show that regional anesthesia is superior to general anesthesia in terms of major maternal or neonatal outcomes. Further research to evaluate neonatal morbidity and maternal outcomes, such as satisfaction with technique, will be useful.”

 

reference participants’ characteristics intervention group/ control group

 

 outcomes critical appraisal/ conclusion
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.”

reference participants’ characteristics intervention group/ control group

 

 outcomes critical appraisal/ conclusion
Paech 2000

Postoperative intraspinal opioid analgesia after caesarean section; a randomised comparison of subarachnoid morphine and epidural pethidine. International

 

International Journal of Obstetric Anesthesia 9, 238-245

 

 inclusion criteria

– not reported

exclusion criteria

– concurrent opioid therapy

– contraindications to spinal anaesthesia or NSAIDs

– refusal to use PCA

– intolerance to codeine, morphine or pethidine

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group PCEA: 31 ± 5

group iPCA: 32 ± 5

group P: 32 ± 5

weight [kg]: mean ± SD

group PCEA: 82 ± 16

group iPCA: 80 ± 17

group P: 80 ± 15

repeat caesarean: n/ N

group PCEA: 32/ 44

group iPCA: 29/ 45

group P: 28/ 48

gestation (wk.): mean ± SD

group PCEA: 38 ± 1

group iPCA: 38 ± 1

group P: 38 ± 1

patient flow and follow up:

total patient number included:

144

randomised in:

group sizes unclear

excluded: 7

– incorrect dose of IT morphine: 1

– co-administration of fentanyl IT: 6

incomplete evaluation: 7

group PCEA: 6

– epidural catheter dislodged: 3

– withdrawal due to inconvenience of PCA: 3

group iPCA: 0

group P: 1

– withdrawal due to inconvenience of PCA: 1

analysed: 137

group PCEA: 44

group iPCA: 45

group P: 48

follow-up:

48 hours

 premedication

10 mg metoclopramide IV

mode of anaesthesia

CSEA: 0.5% hyperbaric bupivacaine 2.5 mL IT, 0.5% plain bupivacaine 2 mL epidurally

surgical approach

not reported

all groups
crystalloid approx. 10 mL/kg and IV epinephrine for prophylaxis of hypotension

intraoperative pain management

ketamine 5 mg (=15 mg) IV for breakthrough pain

postoperative pain management

group PCEA:

epidural pethidine 20 mg (5 mg/mL 15 min lockout) via PCA,

oral capsules (placebo) as requested

group iPCA:

IT morphine 200 µg at the time of IT injection and intravenous pethidine 10 mg bolus (5 mg/mL, 5 min lockout) via PCA,

oral capsules (placebo) as requested

group P:

IT morphine 200 µg at the time of IT injection and oral paracetamol 1 g and codeine 60 mg, 6 hourly as requested

all groups

rectal diclofenac sodium 100 mg 12 hourly after surgery

 time to first request of supplemental analgesia [min]: median (IQR)

group PCEA: 115 (95, 175)

group iPCA and group P combined: 305 (155, 725)

(p<0.0001)

number of PCA demands made during 48 h [n]: median (IQR)

group PCEA: 17 (10, 23)

group iPCA: 9 (1, 20)

group P: 10 (2, 17)

(p<0.02)

need for pethidine [mg]: median (IQR)

group PCEA: 300 (180, 420)

group iPCA: 90 (10, 170)

(p<0.001)

median number of oral capsules requested

first 24 h: 0 (0)

over 48 h: 0 (0.2) used by group P

postoperative pain [VAS]

at rest

significantly increased in group PCEA compared with group iPCA and group P only at 8 h

(p<0.001)

on movement

significantly increased in group PCEA compared with group iPCA and group P only in at 8 and 12 h

(p<0.05)

satisfaction

no significant differences between the groups

recovery

time to first ambulation and to first passage of flatus shorter in group PCEA

(p<0.05, p=0.03, respectively)

no significant differences in:

– time to take solid food

– first micturition after urinary catheter was removed

– discharge

adverse effects/ events [n]: median (IQR)

nausea

significantly reduced in group PCEA at 12 h but not afterwards

(p=0.0001)

pruritus

significantly reduced in group PCEA at 12 and 24 h but not at 48 h

(p=0.0001, p=0.01, respectively)

drowsiness

significantly lower in group PCEA compared with group iPCA and group P combined at 12 and 48 h but not at 24 h

(p=0.04, p=0.004, respectively)

 methodological shortcomings

no methodological shortcomings according to the evaluation sheet

level of evidence: 1

authors’ conclusion

“… excellent postoperative analgesia was obtained with either pethidine PCEA or subarachnoid morphine 200 µg after spinal anaesthesia for caesarean section. After the latter, patient preference appeared to favour supplementation with iPCA rather than oral analgesic, although this outcome may have been influenced by the study methodology. Opioid-related side effects were significantly more severe with subarachnoid morphine and affected patient satisfaction. Future studies of subarachnoid morphine should use a lower dose.”

reference participants’ characteristics intervention group/ control group

 

 outcomes critical appraisal/ conclusion
Filos 1994

Hemodynamic and analgesic profile after intrathecal clonidine in humans: A dose-response study.

Anesthesiology, 1994. 81(3): p. 591-601.

 

 inclusion criteria

– first caesarean section

– ASA physical status I

exclusion criteria

– maternal systemic disease

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group 150: 28 ± 5

group 300: 29 ± 5

group 450: 29 ± 5

maternal height [cm]: mean ± SD

group 150: 164 ± 8

group 300: 163 ± 9

group 450: 165 ± 7

maternal weight [kg]: mean ± SD

group 150: 75 ± 9

group 300: 76 ± 8

group 450: 75 ± 8

patient flow and follow up:

total patient number included:

30

randomised in:

group 150: 10

group 300: 10

group 450: 10

excluded:

0

analysed:

all patients analysed

follow-up:

24 hours

 mode of anaesthesia

GA: induced with thiopental (6 mg/kg) and atracurium (0.3 mg/kg),

maintained with oxygen-nitrous oxide, halothane not exceeding 0.5%,

1000 mL Ringer’s lactate, continued with 40 mL/kg for the first 24 h

surgical approach

Pfannenstiel incision (not specified)

postoperative pain management

given 45 min after tracheal extubation, diluted as needed to 3 mL volume in saline:

group 150:

clonidine 150 µg (~2 µg/kg) IT

group 300:

clonidine 300 µg (~4 µg/kg) IT

group 450:

clonidine 450 µg (~6 µg/kg) IT

 

 

supplemental analgesia

meperidine 50 mg IV as needed and patient left study

 

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

at rest (baseline)

group 150: 70 ± 14 (53–90)

group 300: 68 ± 14 (47–85)

group 450: 70 ± 15 (49–92)

(p=NS)

at rest (maximal pain relief)

group 150: 98% ± 2 (94–100)

group 300: 98% ± 2 (95–100)

group 450: 97% ± 4 (86–100)

(p=NS)

on coughing (baseline)

group 150: 81 ± 10 (63–100)

group 300: 82 ± 11 (65–100)

group 450: 82 ± 10 (66–100)

(p=NS)

on coughing (maximal pain relief)

group 150: 86% ± 16 (42–96)

group 300: 92% ± 7 (72–100)

group 450: 94% ± 5 (85–100)

(p=NS)

pain at rest <20 min

group 300 patients experienced significantly lower pain scores between 6 and 20 min than group 150

(p<0.01)

pain scores in group 450 differed significantly between 3 and 20 min compared with those in group 150 patients

(p<0.001)

pain at rest between 20 and 360 min

after initial 20 min period and until 180 min pain score reduction was similar in all three groups

after 240 min, the pain scores of patients in group 300 and 450 were significantly lower than those of patients in group 150 up to 300 min

(p<0.01)

pain at rest after 360 min

pain scores of patients in group 450 were significantly lower than those of group 300 patients between 360 and 480 min

(p<0.05; p<0.01)

pain after deep cough

no significant difference between the three groups

duration of analgesia [min]: mean ± SD (range)

group 150: 402 ± 75 (240–480)*

group 300: 570 ± 76 (420–660)†

group 450: 864 ± 80 (660–900)†

*p<0.01 for comparisons between groups 150 and group 300

†p=0.001 for comparisons between group 150 and group 300 with group 450

supplemental analgesia

not reported

adverse effects/ events

intragroup comparisons

reduction of arterial blood pressure (systolic, diastolic and mean) only in group 150

(p<0.05)

sedation

significantly more sedated in group 450 then group 150 and 300 at 15, 90, 120 and 360 min

group 300 not more sedated than group 150

 

 methodological shortcomings

– allocation concealment not reported

– no sample size calculation

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“These results demonstrate dose-dependent analgesia after intrathecal clonidine at doses as great as 450 µg, The nearly immediate analgesic effect observed after intrathecal injection of 300 and 450 µg clonidine strongly argues for a spinal rather than a systemic site of action of this a2-adrenergic agonist. After 300 and 450 µg intrathecal clonidine a relative hemodynamic stability is observed, suggesting a pressor effect at peripheral sites.”
Mendez 1990

Epidural clonidine analgesia after cesarean section.

 

Anesthesiology, 1990. 73(5): p. 848-852.

 

 inclusion criteria

– ASA physical status I/II

– epidural anaesthesia

exclusion criteria

– preeclampsia

– taking opioids, tricyclic antidepressants or clonidine

– >50 mL local anaesthetic or supplemental IV analgesia intraoperatively

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group C400: 29 ± 1

group C800: 29 ± 1

group P: 29 ± 1

maternal height [cm]: mean ± SD

group C400: 162 ± 2

group C800: 164 ± 2

group P: 165 ± 2

maternal weight [kg]: mean ± SD

group C400: 77 ± 4

group C800: 81 ± 3

group P: 81 ± 3

patient flow and follow up:

total patient number included:

60

randomised in:

group C400: 20

group C800: 20

group P: 20

excluded:

unclear

analysed:

unclear

follow-up:

24 hours

 mode of anaesthesia

EA: 0.5% bupivacaine

surgical approach

not reported

postoperative pain management

epidural infusion of

group C400:

clonidine 400 µg bolus plus 10 µg/h

group C800:

clonidine 800 µg bolus plus 20 µg/h

group P:

equal volume of saline (10 mL bolus over 30 min, 2 mL/h)

supplemental analgesia

morphine via iPCA (dose 2 mg, lockout 10 min, </=12 mg/h)

 time to first analgesic request [h]: median

group C400: 4.5*

group C800: 5.0*

group P: 2.0

(*p<0.05 clonidine (both doses) versus saline)

morphine requirements via iPCA [mg]: mean ± SD

group C400: 40 ± 5

group C800: 23 ± 4*

group P: 49 ± 5

(*p<0.05 only group C800 compared with group P)

postoperative pain:

patients with no pain during the first 6 h: %

group C400: 89*

group C800: 88*

group P: 67

(*p<0.01 saline compared with both clonidine doses)

adverse effects/ events

blood pressure from 2–12 h

significantly lower in group C400 compared with group C800 and group P

(p<0.05)

heart rate

compared to group P, clonidine decreased heart rate for 16 h, no difference between group C400 and group C800

asymptomatic bradycardia

one patient had to be treated

respiratory rate

similar between the three groups

sedation: grade 3 motor blockade at 3h: %

group C400: 55

group C800: 80*

group P: 25

(*p<0.05, group C800 compared to group P)

 methodological shortcomings

– generation of allocation sequence not reported

– allocation concealment not reported

– no sample size calculation

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“… epidural administration of clonidine (400 and 800 µg) after caesarean section produces complete analgesia of 4-5 h duration, although analgesia in the current study may have been due in part to prolongation of residual epidural anaesthesia. Continuous infusion of 20 but not 10 µg/h clonidine reduces supplemental morphine usage, and neither infusion regimen produces significant hypotension. Sedation and, rarely, bradycardia may limit bolus clonidine administration. These data provide the basis for designing bolus and infusion regimens in this patient population to produce sustained and complete analgesia.”
Benhamou 1998

Intrathecal clonidine and fentanyl with hyperbaric bupivacaine improves analgesia during caesarean section

 

Obestric Anesthesia 1998. 87: p.609-613

 inclusion criteria

– ASA physical status I/II

– singleton fetus term pregnancy

– height 155–180 cm

exclusion criteria

– not reported

demographic data

no significant differences in baseline characteristics

maternal age [yr]: mean ± SD

Group B: 31 ± 5

Group BC: 30 ± 5

Group BCF: 31 ± 6

height [cm]: mean ± SD
Group B: 162 ± 7

Group BC: 161 ± 6

Group BCF: 163 ± 6

weight [kg]: mean ± SD
Group B: 67 ± 9

Group BC: 73 ± 14

Group BCF: 74 ± 12

mode of anaesthesia: CSEA (n)

Group B: 14

Group BC: 10

Group BCF: 10

patient flow and follow up

total patient number included:

78

randomised in:

Group B: 26

Group BC: 26

Group BCF: 26

excluded
–

analysed:

Group B: 26

Group BC: 26

Group BCF: 26

follow up:

not reported

 

 prior to anaesthesia

– sodium citrate 30 mL or effervescent cimetidine (200 mg) 15 min before SpA

– 20 mL/kg of IV lactated Ringer‘s solution

anaesthesia

– SpA or CSEA depending on the centres in which caesarean section took place

Group B:

hyperbaric bupivacaine 0.06 mg/cm of body height and 1 mL saline

Group BC:

hyperbaric bupivacaine 0.06 mg/cm of body height with clonidine 75 µg (0.5 mL) and saline (0.5 mL)

Group BCF:

hyperbaric bupivacaine 0.06 mg/cm of body height and fentanyl (12.5 µg in 0.5 mL) added to clonidine (75 µg)

surgical approach
not reported.

intraoperative pain management

-patients who had a single-shot SpA: repeated bolus of 25 µg of IV fentanyl (</= 100 µg)
– patients who had an epidural catheter: repeated bolus of 2% lidocaine (5 mL) with 1:200,000 epinephrine (</= 20 mL)

 supplemental analgesia to reach T4 level (%)

Group B: 18

Group BC: 0*

Group BCF: 0*

* p=0.01 for groups BC and BCF versus B

intraoperative pain: %

Group B: 35

Group BC: 23*

Group BCF: 0*

* p=0.05 for groups BC and BCF versus B

first analgesic request (min): mean ± SD

Group B: 137 ± 35

Group BC: 183 ± 80

Group BCF: 215 ± 79 #

# p<0.05 for group BFC versus the other groups

intraoperative nausea-vomiting: %
Group B: 41

Group BC: 14*

Group BCF: 13*

* p<0.05 for groups BC and BCF versus B

shivering: %

Group B: 11

Group BC: 17

Group BCF: 4

sedation: %

Group B: 29

Group BC: 40

Group BCF: 65#

# p<0.05 for group BCF versus the other groups

pruritus: %

Group B: 0

Group BC: 0

Group BCF: 25#

# p<0.05 for group BCF versus the other groups

APGAR-Score
no significant differences

 methodological shortcomings

– blinding of the outcome assessor not reported

– allocation concealment not reported

level of evidence: 1

authors’ conclusion

“… the study demonstrates improved intraoperative analgesia by adding clonidine to bupivacaine. By using a small dose of intrathecal clonidine, side effects were not increased. The combination of clonidine and fentanyl further improved analgesia.”
Filos 1992

Intrathecal clonidine as a sole analgesic for pain relief after caesarean section

Anesthesiology 1992. 77: p.267-274

 inclusion criteria

– ASA physical status I

– no previous labour

exclusion criteria

– maternal systemic disease

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group C:  28.7 ± 4.7

group P:  31.6 ± 6.1

weight [kg]: mean ± SD

group C:  85.6 ± 8.2

group P:  79.3 ± 6.8

height [cm]: mean ± SD

group C:  161.9 ± 5.4

group P:  161.8 ± 3.6

patient flow and follow up:

total patient number included:

20

randomised in:

group C: 10

group P:  10

excluded:

–

analysed:

group C: 10

group P:  10

follow-up:

24 hours

 anaesthesia

GA:
induced with:

thiopental (6 mg/kg) and paralyses with atracurium (0.3 mg/kg)

maintained with:

oxygen-nitrous oxide, supplemented with halothane </=0.5 vol%

intraoperatively 1000 mL Ringer‘s lactate

surgical approach
not reported.

postoperative analgesia

Group C:

– 150 µg clonidine IT (3 mL)

Group P: 
– saline IT (3mL)

postoperatively all patients received 40 mL/kg lactated Ringer‘s solution for the first 24 h

rescue analgesia

50 mg intravenous meperidine (then patient had to leave the study)

 

 duration of analgesia [min]: mean ± SD
Group C:  414.0 ± 127.9Group P: 181.5 ± 168.9
(p<0.05)pain scores at rest [VPLA, VPLAC]
significantly less in group C from 20 to 120 min after IT administration(p<0.05)pain scores after cough [VPLA, VPLAC]
significantly less in group C from 6 to 360 min after IT administration(p<0.05)adverse effects/ eventssignificantly increased in group C:- hypotension- sedation- dryness of mouth 		 methodological shortcomings

– blinding of the outcome assessor unclear

– allocation concealment not reported

– incomplete outcome data

– no sample size calculation

level of evidence: 1

authors’ conclusion

“ … in this placebo-controlled study we demonstrated that 150 µg of clonidine IT induces effective analgesia of medium duration after caesarean section, but not without side effects such as hypotension, sedation and dryness of mouth…”
Lavand”homme 2008
An evaluation of the postoperative antihyperalgesic and analgesic effects of intrathecal clonidine administered during elective caesarean sectionObstetric Anaesthesiology 2008, 107 (3):p. 948-955		 inclusion criteria

– ASA I or II

exclusion criteria

– preterm pregnancy (<37 weeks)

– multiple gestation

– asthma or cardiovascular disease

– allergy to NDAIDS

– >1 previous caesarean section

– conversion to GA because of failed SpA

– history of established chronic pain (low back pain or headaches)

– recent use of opioid analgesics or antidepressant drugs

demographic data

no significant differences in baseline characteristics

maternal age [yr]: mean ± SD

Group BS: 33 ± 5

Group BSC: 35 ± 5

Group BC: 33 ± 6

gestational age [wks]: mean ± SD

Group BS: 38 ± 1

Group BSC: 38 ± 1

Group BC: 39 ± 1

height [cm]: mean ± SD
Group BS: 165 ± 8

Group BSC: 165 ± 7

Group BC: 164 ± 7

weight [kg]: mean ± SD
Group BS: 82 ± 17

Group BSC: 75 ± 15

Group BC: 75 ± 11

previous caesarean section [%]: 
Group BS: 47

Group BSC: 36

Group BC: 52

previous abdominal surgery [%]: 
Group BS: 23

Group BSC: 26

Group BC: 21

previous pain condition [%]: 
Group BS: 17

Group BSC: 19

Group BC: 21

patient flow and follow up

total patient number included:

96

follow-up at 24 and 48 h:
randomised in:

Group BS: 32

Group BSC: 32

Group BC: 32

excluded:
–

analysed:
all patients

follow-up at 1,3 and 6 months afterwards

completed F-up:

Group BS: 30

Group BSC: 31

Group BC: 29

follow up:

6 months

 

 prior to anaesthesia

– IV ranitidine 50 mg

– metoclopramide 10 mg

– oral sodium citrate 0.3 M 30 mL

– preload of 500 mL IV salt solution

spinal anaesthesia

Group BS:

hyperbaric bupivacaine with sufentanil 2 µg

Group BSC:

hyperbaric bupivacaine with sufentanil 2 µg and clonidine 75 µg

Group BC:

hyperbaric bupivacaine and clonidine 150 µg

bupivacaine dose was adjusted based on patient height:
9 mg when <160 cm,

10 mg for height between 160 and 175 cm,

11 mg when >175 cm

surgical approach
Pfannenstiel incision with peritoneal closure

postoperative pain management

– all patients received IV diclofenac 150 mg daily

– IV paracetamol 1 g every 6 h as needed.

-IV morphine via PCA (demand bolus: 1 mg, lockout time: 5 min, </=25 mg/4 h)

 

 punctate mechanical hyperalgesia surrounding the wound at 24 h and 48 h:
smaller in Group BC than BS
(p=0.02)incidence of punctate mechanical hyperalgesia at 48 h:
smaller in Group BC than BS
(p=0.03)incision pain at rest and on movement [VAS]:
no significant differences between the groupspostoperative PCA morphine requirement:no significant differences between the groupsfirst use of PCA device [min]: mean ± SDGroup BS: 135 ± 29Group BSC: 246 ± 55*Group BC:170 ± 39
*significantly delayed in group BSC compared to the other groupsparacetamol use (frequency and dose):no significant differences between the groupsresidual pain after 1,3 and 6 months:

no significant differences between the groups

adverse events/ effects:

no major side effects

incidence of hypotension:
no significant differences between the groups

mild sedation: 
more frequent in group BC

 

 methodological shortcomings

no methodological shortcomings according to the evaluation sheet

level of evidence: 1

authors’ conclusion

“Intrathecal clonidine 150 µg combined with bupivacaine had a

postoperative antihyperalgesic effect expressed as a significant reduction in the extent and incidence of periincisional punctate mechanical hyperalgesia at 48 h after elective cesarean delivery compared with intrathecal bupivacaine-sufentanil and intrathecal clonidine 75 µg bupivacaine-sufentanil.”
Paech 2004
Postcesarean analgesia with spinal morphine, clonidine or their combinationAnaesthesia Analgesia 2004, 98: p. 1460- 1466		 inclusion criteria

– healthy parturients with singleton fetus

– spinal anaesthesia

exclusion criteria

– preterm gestation

– hypertensive disorders of pregnancy

– multiple pregnancy

– opioid exposure during pregnancy

– contraindications to regional anaesthesia or the postoperative administration of NSAIDs

demographic data

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

Group M100: 31.3 ± 6
Group C150: 31.4 ± 6.1
Group MC30: 31.6 ± 5
Group MC60-150: 30.8 ± 4.6

gestational age [wk.]: median (range)

Group M100: 38 (38,39)
Group C150: 38 (38,39)
Group MC30: 38 (38,38)
Group MC60-150:38 (38,39)

weight [kg]: mean ± SD
Group M100: 81.8 ± 15.3
Group C150: 81.8 ± 17
Group MC30: 82.1 ± 16.2
Group MC60-150: 84.8 ± 16.2

repeat caesarean section [n(%)]: 
Group M100: 26 (66.7)
Group C150: 27 (69.2)
Group MC30: 28 (68.2)
Group MC60-150: 81 (71.7)

patient flow and follow up

total patient number included:

240

randomised in:

Group M100: 39

Group C150: 39
Group MC30: 41
Group MC60: 38
Group MC90: 38

Group MC150: 37
after identification of the lowest effective dose of clonidine:

Group M100: 39
Group C150: 39
Group MC30: 41
Group MC 60-150: 113

excluded:
8

analysed:
232

follow-up

36 hours

 

 

 prior to anaesthesia

– oral ranitidine and sodium citrate

– IV crystalloid 10 mL/kg

spinal anaesthesia

– hyperbaric 0.5% bupivacaine 2.5 mL plus fentanyl 15 µg

– prophylactic epinephrine infusion IV (30 mg in 500 mL of crystalloid)

– study drug were prepared in normal saline to a total value of 2 mL (immediately injected after bupivacaine)
Group M100: 100 µg morphine

Group C150: 150  µg clonidine

Groups MC (different doses to identify of the smallest effective dose of clonidine):
–MC30: morphine 100 µg plus 30 µg clonidine

– MC60: morphine 100 µg plus 60 µg clonidine

– MC90: morphine 100 µg plus 90 µg clonidine

– MC150: morphine 100 µg plus 150 µg clonidine

surgical approach
not reported

intraoperative analgesia

nitrous oxide or ketamine

postoperative analgesia

– all patients received naproxen 500 mg rectally after completion of surgery, afterwards twice daily PO

– morphine PCA (1 mg demand bolus, 5 min lockout)

 

 pain during surgery:
no significant differencesintraoperative ketamine consumption:
group MC50-150: 2group M100: 1
group C150: 1
group MC30: 1duration of postoperative analgesia:
significantly increased in group M vs each of the groups combining morphine and clonidine 
cumulative morphine consumption at 24 h-36 h:
no significant differences between groupssatisfaction with analgesia:
group MC30 most frequent dissatisfaction due to inadequate pain analgesia
(p<0.01)
time to first PCA pump activation [min] median (range):
Group M100:             157 (120, 201)
Group C150:              266 (183, 320)
Group MC30:             240 (205, 269)
Group MC 60-150      300 (265,349)
groups differed significantlyp<0.0001compared with group M time was significantly longer in both groups MC30 and MC60-150p<0.0001cumulative IV morphine consumption until 36 h postop [median (range)]:significantly increased in group M vs each of the groups combining morphine and clonidine at in time period untilp<0.001 at 24hpain [VAS]

at rest 
significantly different at 2 and 6 h (Group M >C >M30 >M60-150)
with coughing

significantly different at 2, 6, 8, 10 and 14 h

(Group M >C >M30 >M60-150)

VAS with coughing at 12h

significantly higher in group C than group M than group MC60-90 than group MC30

worst pain experienced
significantly different at 4 and 6-12h

(Group M >C >M30 >M60-150)

p<0.01
adverse effect/ events

hypotension
no significant difference between the groups

perioperative nausea
no significant difference between the groups

sedation median (range)

Group M100: 10 (0,38)*
Group C150: 53 (8,80)
Group MC30: 30 (8.54)
Group MC 60-150: 44 (15,63)
*p<0.001 compared with all groups with clonidine

 methodological shortcomings

not analysed as randomised

level of evidence: 1

authors’ conclusion

“… a combination of subarachnoid morphine 100 µg and clonidine for spinal anesthesia for cesarean delivery significantly improves postoperative pain relief, but increases intraoperative sedation and may increase perioperative vomiting. Because there was no difference in primary or secondary outcomes among groups receiving morphine with clonidine 60–150 µg, we conclude that the minimal effective dose range of subarachnoid clonidine, when combined with bupivacaine, fentanyl 15 µg, and morphine 100 µg, is 30–60 µg.“
Singh 2013
The effect of addition of intrathecal clonidine to hyperbaric bupivacaine on postoperative pain after lower segment caesarean section: A randomized control trialSaudi Journal of Anaesthesia 2013, 7(3): p.283-290		 inclusion criteria

– ASA physical status I/II

– singleton fetus at term
– scheduled to undergo elective LSCS under SpA

exclusion criteria

– patients who refused spinal anaesthesia

– patients who had any contraindication to regional anaesthesia

– fetal distress

– preterm gestation

– hypertensive disorders of pregnancy

– multiple pregnancy

– weighted >90 kg

– height <140 cm or >170 cm

– any major co-morbidity

– inability to speak English or Hindi

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

group BF: 24.85 ± 2.58

group BC50: 25.23  ± 3.62

group BC75: 25.71 ± 4.21

weight [kg]: mean ± SD

group BF: 55.73 ± 3.86

group BC50: 57.77 ± 7.96

group BC75: 55.76 ± 7.59

height [cm]: mean ± SD

group BF: 158.24 ± 4.53

group BC50: 158.83 ± 5.04

group BC75: 160.47 ± 3.97

patient flow and follow up:

total patient number included:

105

randomised in:

group BF: 35

group BC50: 35

group BC75: 35

excluded:

after allocation:

Group BC75:

-did not received allocated study drug (n=1)

lost to follow up:
Group BF:

-discontinued intervention (n=2)

Group BC50: 0

Group BC75:

-discontinued intervention (n=1)

analysed:

group BF: 33

group BC50: 35

group BC75: 34

follow-up:

6 hours

 prior to anaesthesia

– ranitidine 50 mg and metoclopramide 10 mg

– preload with 12–15 mL/kg colloid 6

spinal anaesthesia
Group BF:

2 mL of 0.5% hyperbaric bupivacaine + 25 µg fentanyl (0.5 mL)

Group BC50:

2 mL of 0.5% hyperbaric bupivacaine + 50 µg clonidine (0.33 mL, made to 0.5 mL by adding 0.17 mL normal saline)
Group BC75:

2 mL of 0.5% hyperbaric bupivacaine + 75 µg clonidine (0.5 mL)

surgical approach

lower segment caesarean section (not specified)

postoperative pain management

IM diclofenac sodium 1.5 mg/kg

 duration of postoperative analgesia [min] mean (± SD)

Group BF: 184.73 ± 68.64

Group BC50: 360.71 ± 86.51

Group BC75: 760.50 ± 284.03
significant between group BF and BC50 (p<0.001), between BF and BC75 (p<0.001) and between BC50 and BC75(p<0.001)

VAS (VNRS) score at time for first analgesic request
no significant differences between the groups

(p=0.145)

adverse effects/ events

incidence of nausea n(%)

BF: 15 (45.5)*

BC50: 3 (8.60)

BC75: 2 (5.90)

p>0.001 compared to BC50 and BC75

incidence of pruritus n(%)
BF: 11 (33.60)*
BC50: 0 (0)
BC75: 0 (0)
p>0.001 compared to BC50 and BC75

no significant differences in:
– vomiting

– shivering

– dryness of mouth

– sedation

– hypotension
Apgar Score:
no significant differences

 methodological shortcomings

no methodological shortcomings according to the evaluation sheet

level of evidence: 1

authors’ conclusion

“… the duration of postoperative analgesia increases significantly on adding 75 µg clonidine to 2 mL of hyperbaric bupivacaine without any increase in maternal side effects. There was no difference in neonatal outcome.”
vanTuijl 2006
The effect of addition of intrathecal clonidine to hyperbaric bupivacaine on postoperative pain and morphine requirements after caesarean section: a randomized controlled trialBritish Journal of Anaesthesia 97 (3): p. 365-370		 inclusion criteria

– ASA physical status I/II

– 150–195 cm height

– 50–120 kg

exclusion criteria

– conditions that preclude spinal anaesthesia

– psychiatric disorders

– chronic pain

– antihypertensive medication

– unable to communicate in Dutch language

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean (range)

Group B: 35 (19–43)
Group CB: 34 (22–41)

BMI: mean ± SD

Group B: 30 ± 5.7
Group BC: 29 ± 4.1
twins and triples n (%)
Group B: 5 (9.4)
Group BC: 5 (7.5)
repeat caesarean section n (%)
Group B: 25 (47)
Group BC: 19 (36) 
total patient number included:

120

randomised in:

group B: 60

group BC: 60

excluded: 14

Group B:
– withdrew consent after randomisation: n=1

– technical problems with PCA: n=3
– SpA converted to GA: n= 3

Group BC:
– technical problems with PCA: n=5
– SpA converted to GA: n= 2

analysed:
group B: 53

group BC: 53

follow-up

24 hours

 before anaesthesia
– IV Ringer’s lactate 1500 mL or normal salinespinal anaesthesia
Group B:bupivacaine 0.5% (2.2 mL) heavy with 0.5 mL normal saline 0.9% (total 2.7 mL) IT
Group BC:bupivacaine 0.5% (2.2 mL) heavy with clonidine 75 µg in normal saline 0.9% (total 2.7 mL)after injection all patients received ephedrine (10 mg) IV to prevent hypotensionintraoperative pain management
– alfentanil IV incremental doses of 250 µgat the end of surgery– paracetamol (1000 mg) rectally every 6 hpostoperative pain management– IV morphine via PCA (1 mg, lockout interval 10 min)
– if VAS >4: loading dose of 5 mg morphine, repeated if didn’t decrease within 20 min 		 total morphine consumption (mg): mean ± SD
group B: 28.0 ± 14.2
group BC: 24.7 ± 13.8
(p=NS)
number of PCA demands
group B: 32 (27)
group BC: 32 (27)
(p=NS)number of PCA bolus
group B: 23 (13)
group BC: 24 (13)
(p= NS)time to first analgesic request (min): mean ± SD
group B: 55 ± 14.2
group BC: 129 ± 13.8
(p<0.05)VAS score 1h postop
group B: 3.7 (2.3)
group BC: 0.9 (1.4)
(p<0.05)VAS score 24h postop
(p=NS)adverse events/ effects
pruritus 
group B: 10 (9)
group BC: 2 (4)
(p<0.05)nauseagroup B: 11 (21)
group BC: 7 (13)
(p=NS)vomiting
group B: 3 (6)
group BC: 2 (4)
(p=NS)Apgar Score 
no differences between the groups		 methodological shortcomings

– blinding of outcome assessor not reported

– allocation concealment not reported

– incomplete outcome data

level of evidence: 1

authors’ conclusion

“The addition of clonidine 75 µg to hyperbaric bupivacaine prolongs spinal anaesthesia after caesarean section and improves early analgesia, but does not reduce the postoperative morphine consumption during the first 24 h. No clinically relevant maternal or neonatal side-effects were detected. “

 

reference participants’ characteristics intervention group/ control group

 

 outcomes critical appraisal/ conclusion
Hofmeyr 2008

Techniques for caesarean section

 

Cochrane Database of Systematic Reviews

2008, Issue 1. Art. No.: CD004662. DOI: 10.1002/14651858.CD004662.pub2.

 

 databases/ search engines

– Medline

– Central

– Embase

– Cochrane Pregnancy and Childbirth Group’s Trials Register

– hand searches of 30 journals and proceedings of major conferences

search period

through 15.02.2012

inclusion criteria

– randomised controlled trials

– comparing different techniques for caesarean section

exclusion criteria

– quasi randomised studies

included studies (n participants)

[1] Bjorklund 2000 (339)

[2] Dani 1998 (144)

[3] Darj 1999 (50)

[4] Ferrari 2001 (158)

[5] Franchi 1998 (302)

[6] Franchi 2002 (312)

[7] Heimann 2000 (240)

[8] Koettnitz 1999 (86)

[9] Li 2001 (172)

[10] Mathai 2002 (101)

[11] Mokgokong 1974 (412)

[12] Moreira 2002 (400)

[13] Wallin 1999 (72)

[14] Xavier 2005 (162)

 

 Joel-Cohen-based vs Pfannenstiel caesarean section techniques

[2-10,13,14] (11 studies)

Misgav-Ladach technique vs traditional (lower midline abdominal incision) caesarean technique

[1,12] (2 studies)

extraperitoneal vs intraperitoneal caesarean section

[11] (1 study)

 Joel-Cohen-based vs Pfannenstiel caesarean section techniques

‘Joel-Cohen based’ surgery associated with:

less blood loss: WMD [95% CI]

-64.45 mL [-91.34;-37.56]

shorter operating time: WMD [95% CI]

-18.65 min [-24.84;–12.45], I2=93%

wound infections

no overall difference

return of bowel function

no significant differences

time to mobilisation

no significant differences

shorter duration of postoperative pain: WMD [95% CI]

-14.18 h [-18.31;-10.04]

less use of analgesia: WMD [95% CI]

-0.92 [-1.20;-0.63]

Misgav-Ladach vs traditional (lower midline

abdominal incision)

Misgav-Ladach method associated with

reduced blood loss: WMD [95% CI]

-93.00 mL [-132.72; -53.28]

shorter operating time: WMD [95% CI]

-7.30 min [-8.32;-6.28]

shorter time to mobilisation: WMD [95% CI]

-16.06 h [-18.22;-13.90 h]

shorter length of postoperative stay: WMD [95% CI]

-0.82 days[-1.08;-0.56]

no significant differences in:

– postoperative anaemia

– wound infection

– wound breakdown

– endometritis or

– fever

Misgav-Ladach vs modified Misgav-Ladach

methods

Misgav-Ladach method associated with:

longer time from skin incision to birth of the baby: WMD [95% CI]

2.10 min[1.10; 3.10]

no significant differences in:

– blood loss

– time to oral intake

– time to return of bowel function

– postoperative pain score

– operating time or

– length of postoperative stay

extraperitoneal versus intraperitoneal caesarean section

serious complications: (n/N)

extra: 1/173

intra: 12/239

serious complications: RR [95% CI]

0.12 [0.02;0.88]

no significant differences in:

– rate of maternal mortality

– numbers who had repeat procedures on the wound

 

 methodological shortcomings

– publication bias not assessed

level of evidence: 1

authors’ conclusion

“’Joel-Cohen based’ methods have advantages compared to Pfannenstiel and to traditional (lower midline) caesarean section techniques, which could translate to savings for the health system. However, these trials do not provide information on mortality and serious or long-term morbidity such as morbidly adherent placenta and scar rupture.”
Abuelghar 2013

Caesarean deliveries by Pfannenstiel versus Joel-Cohen incision: A randomised controlled trial.

 

Journal of the Turkish German Gynecology Association, 2013. 14(4): p. 194-200.

 

 inclusion criteria

not reported

exclusion criteria

-experienced previous abdominal operations

– previous caesarean section

– any disease that could affect post-operative recovery (cardiac, diabetes mellitus, preeclampsia)

– complicated with extension of the uterine incision during caesarean section

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD (range)

group JC: 26.75 ± 3.7 (20–35)

group P:  26.53 ± 3.65 (20–35)

gestational age [weeks]: mean ± SD (range)

group JC: 38.86 ± 1.4 (38–41)

group P: 38.78 ± 1.2 (38.5–0.5)

parity: mean ± SD (range)

group JC: 1 ± 1.2 (0–4)

group P: 1 ± 1.5 (0–3)

patient flow and follow up:

total patient number included:

153

randomised:

group JC: 76

group P: 77

lost to follow-up

group JC: 12

group P: 13

analysed:

group JC: 64

group P: 64

follow-up:

1 week

 

 mode of anaesthesia

SpA (not specified)

surgical approach

group JC: Joel-Cohen incision

straight transverse incision through the skin only, 3 cm below the anterior superior iliac spines (higher than Pfannenstiel incision), subcutaneous tissues opened in the middle 3 cm, fascia incised transversely in midline then extended laterally with blunt finger dissection, finger dissection used to separate rectus muscles vertically and laterally and to open peritoneum, all layers of abdominal wall stretched manually to the extent of skin incision, bladder reflected inferiorly, myometrium incised transversely in the midline, without breaching the amniotic sac, then opened and extended laterally with finger dissection

group P: Pfannenstiel incision

skin and rectus sheath opened transversely using sharp dissection, rectus sheath dissected free from underlying rectus abdominus muscles, peritoneum opened longitudinally using sharp dissection, uterus opened with transverse lower segment incision, uterine incision closed with two layers of continuous sutures and both peritoneal layers closed with continuous sutures, fascia closed with continuous or interrupted sutures, skin closed with interrupted or continuous sutures.

postoperative pain management

pethidine 50 mg IM on request

 perioperative outcomes: mean ± SD (range)

time [min];

group JC                                group P

operative time:

22.36 ± 2.5 (20–32)                31.59 ± 2.9 (25–36)*

incision to-delivery:

2.88 ± 1.1 (2–5)                     3.75 ± 1.22 (2–9)*

delivery to-closure:

7.86 ± 2.3 (12–25)                24.59 ± 2.5 (20–30)*

*p<0.001

postoperative pain [VAS]: mean ± SD

                  group JC                 group P

at 6 h:        52.8 ± 13.0              67.5 ± 12.1*

at 12 h:      31.5 ± 12.8              43.7 ± 15.4*

at 18 h:      16.3 ± 6.9                23.1 ± 9.5*

*p<0.001

pethidine consumption [doses]: mean ± SD

group JC: 2.4 ± 0.8

group P: 3.0 ± 0.8

(p<0.001)

recovery: mean ± SD (range):

time [h] to:

group JC                             group P

get out from bed

4.92 ± 1.06 (4–-7)               7.13 ± 1.13 (5–10)*

walk straight without support

7.28 ± 1.25 (5–10)              9.53 ± 1.46 (7–13)*

detect audible intestinal sounds

4.82 ± 0.74 (4–6.5)             6.16 ± 0.71 (5–7.7)*

pass gases or stool

9.34 ± 1.83 (7–13)             12.14 ± 2.37 (8–18)*

* p<0.001

postoperative hospital stay: n (%)

                                group JC                group P

0-24 hours              40 (62.5)                 44 (68.8)

24-48 hours            24 (37.5)                 20 (31.2)

(p=NS)

adverse effects/ events

not reported

 

 methodological shortcomings

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“Joel-Cohen incision in the non-scarred abdomen may provide a faster technique for caesarean section with less postoperative pain and probably early postoperative recovery in our circumstances.”

 
Dodd 2008 

Surgical techniques for uterine incision and uterine closure at the time of caesarean section.

 

Cochrane database of systematic reviews (Online), 2008(3): p. CD004732

 databases/ search engines

– Medline

– Central

– Embase

– Cochrane Pregnancy and Childbirth Group’s Trials Register

– hand searches of 30 journals and proceedings of major conferences

search period

through 31.05.2012

inclusion criteria

– randomised controlled trials

– comparing various types of uterine incision and closure of the uterine incision

exclusion criteria

– quasi randomised studies

included studies (n participants)

[1] Batioglu 1998 (118)

[2] Bjorklund 2000 (340)

[3] Dani 1998 (154)

[4] Darj 1999 (50)

[5] Ferrari 2001 (158)

[6] Hamar 2007 (30)

[7] Hauth 1992 (991)

[8] Lal 1988 (100)

[9] Magann 2002 (945)

[10] Moreira 2002 (400)

[11] Rodriguez 1994 (296)

[12] Villeneuve 1990 (200)

[13] Von Rechenberg 1990 (100)

[14] Wallin 1999 (72)

[15] Xavier 2005 (162)

 

 [1] Batioglu 1998

single layer uterine closure versus double layer uterine closure

[2] Bjorklund 2000

single layer uterine closure (Misgav Ladach procedure) versus double layer uterine closure

[3] Dani 1998

single layer uterine closure versus double layer uterine closure

[4] Darj 1999

single layer uterine closure versus double layer uterine closure

[5] Ferrari 2001

single layer uterine closure versus double layer uterine closure

[6] Hamar 2007

single layer uterine closure versus double layer uterine closure

[7] Hauth 1992

single layer uterine closure versus double layer uterine closure

[8] Lal 1988

single layer uterine closure versus double layer uterine closure

[9] Magann 2002

blunt dissection of the uterine incision versus sharp dissection of the uterine incision

[10] Moreira 2002

single layer uterine closure versus double layer uterine closure

[11] Rodriguez 1994

blunt dissection of the uterine incision versus sharp dissection of the uterine incision

[12] Villeneuve 1990

auto suture device versus standard hysterotomy

[13] Von Rechenberg 1990

auto suture device versus conventional incision (no further information provided)

[14] Wallin 1999

single layer uterine closure versus double layer uterine closure

[15] Xavier 2005

single layer uterine closure versus double layer uterine closure

 transverse lower uterine segment incision versus other types of uterine incision

no studies identified

methods of performing the uterine incision: auto stapler versus conventional

no difference in febrile morbidity: risk ratio (95% CI)

0.92 (0.38;2.20) [12,13]

no difference in mean blood loss: MD (95% CI)

-87.0 (-175.09;1.09) [12]

no difference in duration of surgery: MD (95% CI)

3.30 (-0.02;6.62) [12]

no difference in duration of postnatal stay: MD (95% CI)

0.0 (-0.28;0.28) [12]

no difference in wound complications: risk ratio (95% CI)

1.5 (0.67,3.35) [13]

no difference in need for blood transfusion: risk ratio (95% CI)

1.5 (0.26;8.60) [13]

no difference in endometritis: risk ratio (95% CI)

0.2 (0.02;1.65) [13]

methods of performing the uterine incision: blunt versus sharp dissection

no difference in endometritis: risk ratio (95% CI)

0.88 (0.72;1.09) [9,11]

lower mean blood loss with blunt extension: MD (95% CI)

-43.0 (-66.12;-19.88) [9]

no difference in need for blood transfusion: risk ratio (95% CI)

0.22 (0.05;1.01) [9]

single layer uterine closure versus double layer uterine closure

no difference in postoperative febrile morbidity (including endometritis): risk ratio (95% CI)

1.07 (0.70;1.64) [2,5,10,14,15]

single layer closure associated with reduced mean blood loss: MD (95% CI)

-70.11 (-101.61;-38.60) [2,5,6]

no difference in blood loss greater than 500 mL: risk ratio (95% CI) [2]

0.70 (0.42;1.18)

no difference in need for blood transfusion: risk ratio (95% CI)

0.80 (0.34;1.92) [7]

no difference in wound infection: risk ratio (95% CI)

1.27 (0.95;1.70) [7,14,15]

no difference in operative procedure on wound: risk ratio (95% CI)

0.34 (0.04;3.19) [2]

no difference in postoperative anaemia: risk ratio (95% CI)

1.05 (0.83;1.32) [2,7]

single layer closure associated with reduced duration of procedure: MD (95% CI)

-7.43 (-8.41;-6.46) [1,2,5,6]

no difference in complication of future pregnancy: risk ratio (95% CI)

3.21 (0.13;77.55) [7]

single layer closure associated with reduced postoperative pain present: risk ratio (95% CI)

0.69 (0.52;0.91) [5]

no difference in length of hospital stay: risk ratio (95% CI)

-0.10 (-0.52;0.32) [5]

 methodological shortcomings

– publication bias not assessed

– literature search not comprehensive

level of evidence: 1

authors’ conclusion

“Despite caesarean section being a common operation, there is little high quality information available to inform the most appropriate surgical procedure to adopt. There is no information available to inform the most appropriate uterine incision, or the optimal suture material or suture technique for the uterine incision. There is little information to support the most appropriate method of performing the uterine incision (blunt versus sharp dissection) or to support the use of an auto-suture device. While single layer closure of the uterine incision is associated with a reduction in blood loss and the duration of the procedure, there were other aspects of the intervention which could impact significantly on these findings”
Mathai 2013

Abdominal surgical incisions for caesarean section.

 

Cochrane Database Syst Rev, 2013. 5: p. Cd004453.

 databases/ search engines

– Medline

– Central

– Embase

– Cochrane Pregnancy and Childbirth Group’s Trials Register

– hand searches of 30 journals and proceedings of major conferences

search period

through 28.02.2013

inclusion criteria

– randomised controlled trials

– comparing different abdominal incisions

exclusion criteria

– quasi randomised studies and cross-over trials

included studies (n participants)

[1] Berthet 1989 (58)

[2] Franchi 2002 (312)

[3] Giacalone 2002 (97)

[4] Mathai 2002 (101)

 [1] Berthet 1989

Mouchel (muscle-cutting) incision  versus Pfannenstiel incision

[2] Franchi 2002

Joel-Cohen incision versus Pfannenstiel incision for laparotomic access

[3] Giacalone 2002

Maylard (muscle-cutting) incision versus Pfannenstiel incision for

laparotomic access

[4] Mathai 2002

Joel-Cohen incision versus Pfannenstiel incision for laparotomic access

 Joel-Cohen incision versus Pfannenstiel incision

Joel-Cohen incision was associated with:

reduced postoperative febrile morbidity: risk ratio (95% CI)

0.35 (0.14;0.87) [2,4]

reduced need for postoperative analgesia on demand risk ratio (95 CI)

0.55 (0.40;0.76) [4]

reduced time between surgery and first dose of analgesic: MD (95% CI)

0.80 (0.12;1.48) [4]

reduced consumption of total dose of analgesics in 24 h: MD (95% CI)

-0.89 (-1.19;-0.59) [4]

reduced estimated blood loss: MD (95% CI)

-58.0 (-108.51;-7.49) [4]

reduced total operative time: MD (95% CI)

-11.40 (-16.55;-6.25) [4]

reduced delivery time: MD (95% CI)

-1.90 (-2.53;-1.27) [4]

reduced postoperative hospital stay for mother: MD (95% CI)

-1.5 (-2.16, -0.84) [4]

no differences in:

wound infection as defined by trial authors: risk ratio (95% CI)

1.56 (0.45;5.42) [2]

time from surgery to start of breastfeeding: MD (95% CI)

-5.5 (-13.62;2.62) [4]

admissions to special care baby unit – all types: risk ratio (95% CI)

1.19 (0.44;3.20) [2]

admission to special care baby unit – emergency caesarean

section: risk ratio (95% CI)

1.45 (0.54;3.86) [2]

stay in special care nursery: MD (95% CI)

-0.46 (-0.95;0.03) [4]

Joel-Cohen incision versus vertical incision

no studies identified

muscle cutting incision versus Pfannenstiel incision

no differences in:

postoperative febrile: risk ratio (95% CI)

1.26 (0.08;19.50) [3]

blood transfusion: risk ratio (95% CI)

0.42 (0.02;9.98) [3]

wound infection as defined by trial authors: risk ratio (95% CI)

1.26 (0.27;5.91) [3]

long-term complication – physical test at 3 months (Janda’s test): MD (95% CI)

0.10(-0.73;0.93) [3]

postoperative hospital stay for mother: MD (95% CI)

0.40 (-0.34;1.14) [3]

 methodological shortcomings

– publication bias not assessed

– literature search not comprehensive

level of evidence: 1

authors’ conclusion

“The Joel-Cohen incision has advantages compared with the Pfannenstiel incision. These are: less fever, pain and analgesic requirements; less blood loss; shorter duration of surgery and hospital stay. These advantages for the mother could be extrapolated to savings for the health system. However, these trials do not provide information on severe or long-term morbidity and mortality.”

reference participants’ characteristics intervention group/ control group

 

 outcomes critical appraisal/ conclusion
Bamigboye 2003

Closure versus non-closure of the peritoneum at caesarean section.

 

Cochrane Database Syst Rev, 2003(4): p. Cd000163.

 databases/ search engines

– Medline

– Central

– Embase

– Cochrane Pregnancy and Childbirth Group’s Trials Register

– hand searches of 30 journals and proceedings of major conferences

search period

through 30.04.2010

inclusion criteria

– randomised controlled trials and quasi randomised studies

– comparing leaving peritoneum unsutured with suturing the peritoneum

included studies (n participants)

[1] Chanrachakul 2002 (60)

[2] Galaal 2000 (60)

[3] Grundsell 1998 (361)

[4] Hojberg 1998 (40)

[5] Hull 1991 (113)

[6] Irion 1996 (280)

[7] Nagele 1996 (549)

[8] Pietrantoni 1991 (248)

[9] Rafique 2002 (100)

[10] Saha 2001 (100)

[11] Sood 2004 (149)

[12] Tuncer 2003 (80)

[13] Weerawetwat 2004 (360)

[14] Zhang 2000 (318)

 

 [1] Chanrachakul 2002

non-closure of both peritoneal surfaces versus closure of both peritoneal surfaces

[2] Galaal 2000

non-closure of both peritoneal surfaces versus both peritoneal surfaces closed

[3] Grundsell 1998

both visceral and parietal peritoneum were left unsutured versus both the visceral and parietal peritoneum were closed with a running, delayed absorbable suture

[4] Hojberg 1998

non-closure of parietal peritoneum and closure of visceral peritoneum versus both peritoneal surfaces closed

[5] Hull 1991

both visceral and parietal peritoneum were left unsutured versus both the visceral and parietal peritoneum were closed with a running, delayed absorbable suture

[6] Irion 1996

both the visceral and parietal peritoneum were left unsutured versus both the visceral and parietal peritoneum were re-approximated using continuous, running, delayed absorbable sutures

[7] Nagele 1996

non-closure versus closure of the visceral peritoneum

[8] Pietrantoni 1991

non-closure of parietal peritoneum but closure of the visceral peritoneum versus both visceral and parietal peritoneum sutured

[9] Rafique 2002

non-closure versus control group

[10] Saha 2001

non-closure versus closure of visceral peritoneum

[11] Sood 2004

non-closure of both parietal and visceral peritoneum versus both visceral and parietal peritoneum were closed

[12] Tuncer 2003

non-closure of parietal peritoneum and visceral peritoneum versus both peritoneal surfaces closed

[13] Weerawetwat 2004

non closure of both peritoneum versus closure of only parietal peritoneum versus closure of both peritoneum

[14] Zhang 2000

peritoneal non-closure versus closure

 non-closure of both visceral and parietal peritoneum compared with closure of both peritoneal layers non-closure of both visceral and parietal peritoneum was associated with:

shorter operating time: MD (95% CI)

-6.05 (-6.74;-5.37) [1-3,5,6,9,11,12,14]

less analgesic doses required: MD (95% CI)

-0.20 (-0.33;-0.08) [5,6,11,12]

lower incidence of postoperative fever: risk ratio (95% CI)

0.73 (0.55;0.97) [1-3,5,6,11]

less postoperative days in hospital: MD (95% CI)

-0.40 (-0.50,-0.30) [1-3,5,6,9,11,12]

no differences in:

endometritis: risk ratio (95% CI)

1.11 (0.60;2.02) [3,5,11,13]

wound infection: risk ratio (95% CI)

0.63 (0.35;1.12) [2,3,5,11,13]

postoperative adhesions: risk ratio (95% CI)

1.44 (0.73;2.83) [6,13]

secondary infertility (95% CI): risk ratio

0.89 (0.23;3.44) [6]

non-closure of the visceral peritoneum only compared with closure of both peritoneal layers

non-closure of the visceral peritoneum only was associated with:

shorter operating time: MD (95% CI)

-6.30 (-9.22;-3.38) [7]

lower incidence of postoperative fever: risk ratio (95% CI)

0.63 (0.44;0.90) [7,10,13]

less postoperative days in hospital: MD (95% CI)

-0.70 (-0.98;-0.42) [7]

lower incidence of wound infection: risk ratio (95% CI)

0.36 (0.14;0.89) [7,13]

no differences in:

adhesion formation: risk ratio (95% CI)

1.25 (0.28;5.54) [13]

endometritis: risk ratio (95% CI)

3.0 (0.12;72.91) [13]

non-closure of parietal peritoneum only compared with closure of both peritoneal layers

non-closure of parietal peritoneum only was associated with:

shorter operating time: MD (95% CI)

-5.10 (-8.71;-1.49) [8]

no differences in:

postoperative fever: risk ratio (95% CI)

0.18 (0.01;3.56) [4]

endometritis: risk ratio (95% CI)

0.88 (0.53;1.46) [8]

postoperative days in hospital: MD (95% CI)

0.22 (-0.05;0.48) [4,8]

wound infection: risk ratio (95% CI)

0.95 (0.14;6.66) [8]

 

 methodological shortcomings

– publication bias not assessed

– literature search not comprehensive

level of evidence: 1

authors’ conclusion

“There was improved short-term postoperative outcome if the peritoneum was not closed. This in itself can support those who opt not to close the peritoneum. Long-term studies following caesarean section are limited; there is therefore no overall evidence for non-closure until long-term data become available.”
Tabasi 2013

Closure or non-closure of peritoneum in cesarean section: outcomes of short-term complications.

 

Arch Trauma Res 1(4): 176-179.

 

 

 exclusion criteria

– former CS and/or abdominal surgery

– hypertension

– diabetes mellitus

– premature rupture of membrane

-preoperative bleeding

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

closure: 25.2 ± 5.1

non-closure: 24.3 ± 5.2

parity: primigravida [n (%)]/ multipara [n (%)]:

closure: 39 (78)/ 11(22)

non-closure: 37 (74)/ 13 (26)

gestational age [wk]: mean ± SD

closure: 38.83 ± 0.32

non-closure: 38.24 ± 0.52

indication of caesarean delivery: n (%)

fetal cause/ maternal-fetal cause/ maternal cause

closure: 17 (34)/ 20 (40)/ 13 (26)

non-closure: 18 (36)/ 15 (30)/ 17 (34)

patient flow and follow up:

total patient number included:

100

randomised in:

closure: 50

non-closure: 50

excluded:

0

analysed:

all randomised patients analysed

follow-up:

24 hours

 mode of anaesthesia

SpA: not specified

surgical approach

transverse incision

(no specified)

closure:

closure of visceral and parietal peritoneum

non-closure:

no peritoneum closure

postoperative pain management

after delivery

rectal diclofenac 100 mg,

IM morphine 5 mg

supplemental analgesia

VAS</=70

rectal diclofenac

VAS>70

IM morphine

 

 duration of surgery

shorter in non-closure group (6.89 min)

(p<0.05)

postoperative pain

lower in non-closure group

(p<0.05)

n (%)                closure non-closure

mild                  2 (4)      7 (14)

moderate          29 (58)  40 (80)

severe              19 (38)  3 (6)

(p=0.0003)

supplemental analgesia

lower in non-closure group

(p<0.05)

n (%)                             closure            non-closure

no need                        24 (48)  41 (82)

rectal diclofenac            21 (42)  7 (14)

morphine                      5 (10)    2 (4)

(p=0.0003)

adverse effects/ events

– endometritis (n=1 in non-closure)

– mastitis (n=1 in non-closure)

no cases of:

– wound infections

– blood transfusions

– any further surgery

 methodological shortcomings

– allocation concealment not reported

– no sample size calculation

level of evidence: 1

authors’ conclusion

“… non-closure of both visceral and the parietal peritoneum produces a significant reduction in pain, fewer analgesic requirements and a shorter operation duration without increasing the febrile morbidity and changes in hemoglobin levels as compared to the standard methods.”
Altinbas 2013

Parietal peritoneal closure versus non-closure at caesarean section: which technique is feasible to perform?

 

J Matern Fetal Neonatal Med 26(11): 1128-1131

 

 exclusion criteria

– diabetes mellitus

– moderate-severe hypertension

– anticoagulation therapy

– history of other major abdominal surgery

– multiple gestations

– history of any thrombophilic disorders

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

closure: 27.9 ± 5.17

non-closure: 30.1 ± 5.92

BMI [kg/m2]: mean ± SD

closure: 30.4 ± 4.42

non-closure: 30.02 ± 5.12

gravida: median (IQR)

closure: 2 (2–3)

non-closure: 2 (2–3)

parity: median (IQR)

closure: 1 (1–2)

non-closure: 1 (1–2)

patient flow and follow up:

total patient number included:

110

randomised in:

closure: 55

non-closure: 55

excluded:

0

analysed:

all randomised patients analysed

follow-up:

hospital stay (not specified)

 mode of anaesthesia

SpA: bupivacaine 15–20 mg

surgical approach

Pfannenstiel techniques

closure:

closure of parietal peritoneal layer

non-closure:

non-closure of parietal peritoneal layer

postoperative pain management

during closure

IM diclofenac 75 mg and IV tramadol 100 mg

first and second day

all patients paracetamol 500 mg at every 6 h

 

 duration of surgery [min]: mean ± SD

closure: 30.8 ± 7.63

non-closure: 31.6 ± 10.38

(p=NS)

postoperative pain: median (IQR)

closure: 2 (2–6)

non-closure: 2 (2–4)

(p=NS)

supplemental analgesia

lower in non-closure group

(p<0.05)

recovery

time to passage of flatus

closure: 18.2 ± 6.04

non-closure: 18.21 ± 4.23

time to mobilisation: median (IQR)

closure: 12 (8–12)

non-closure: 8 (8–10)

(p<0.001)

time to oral intake

closure: 12 (8–12)

non-closure: 8 (8–10)

(p<0.001)

adverse effects/ events

no major intraoperative or postoperative complications observed

prolonged hospitalisation because of fever: n (%)

closure: 3 (5.5)

non-closure: 4 (7.3)

(p=NS)

wound infection: n

closure: 2

non-closure: 2

(p=NS)

 methodological shortcomings

– generation of allocation sequence not reported

– blinding of participants, personnel and outcome assessor not reported

level of evidence: 1

authors’ conclusion

“…closure of the parietal peritoneum has no benefit over non-closure of parietal peritoneum and non-closure is associated with rapid postoperative recovery”
Shahin 2009

Parietal peritoneal closure and persistent postcesarean pain.

 

International journal of gynaecology and obstetrics, 2009 104: p. 135-9

 

 inclusion criteria

– pregnancy duration >/=37 weeks

– no scars from prior abdominal surgery

exclusion criteria

– labour pain

– urinary tract infection

– anaemia

– physiological disturbance

– chronic pain

– emergency caesarean delivery

– gastrointestinal complaints necessitating treatment

– unsuccessful SpA

demographic data:

no significant differences in baseline characteristics

maternal age [yr.]: mean ± SD

closure: 25.8 ± 4.7

non-closure: 25.9 ± 4.2

gestational age [weeks]: mean ±SD

closure: 38.4 ±1.2

non-closure: 38.3 ±1.5

parity: mean ±SD

closure: 2.7 ±1.3

non-closure: 2.7 ±1.4

patient flow and follow up:

total patient number included:

340

randomised:

closure: 170

non-closure: 170

excluded:

closure: 9

non-closure: 6

(lost to follow up)

analysed:

closure: 161

non-closure 164

follow-up:

8 months

 

 prior to anaesthesia

cefazolin 1g IV

mode of anaesthesia

SpA using 10 mg of heavy bupivacaine 0.5% in a 2mL volume

surgical approach

Pfannenstiel incision

intervention and control group

visceral peritoneum was left open in all patients

closure: group

parietal peritoneal closure

non-closure group

parietal peritoneal non-closure

postoperative pain management

– paracetamol 1g IV every 6h for the first 36h

– then ibuprofen 10mg rectally

– then ibuprofen 400mg PO every 4–6h for the first 72h

– morphine 2mg IV for rescue analgesia

 rescue analgesia [n (%)]

closure: 88 (54.7)

non-closure:48 (29.3)

(p<0.001)

abdominal pain

POD 1 [VAS]: mean ± SD

closure: 5.6 ± 1.4

non-closure: 4.2 ± 1.8

(p<0.001)

POD 15 [NRS]: mean ± SD

closure: 5.8 ± 1.2

non-closure: 5.8 ± 1.2

(p=NS)

after 8 months [NRS]: mean ± SD

closure: 3.8 ± 2.2

non-closure: 3.2 ± 1.8

(p<0.01)

epigastric pain

POD 1 [VAS]: mean ± SD

closure: 5.8 ± 1.2

non-closure: 4.6 ± 1.0

(p<0.01)

POD 15 [NRS]: mean ± SD

closure: 3.9 ± 1.6

non-closure: 3.1 ± 1.2

(p<0.001)

after 8 months [NRS]: mean ± SD

closure: 3.2 ± 2.0

non-closure: 3.0 ± 1.7

(p=NS)

wound pain

POD 1 [VAS]: mean ± SD

closure: 4.2 ± 1.4

non-closure: 3.0 ± 1.2

(p<0.001)

POD 15 [NRS]: mean ± SD

closure: 1.9 ± 1.4

non-closure: 1.4 ± 1.2

(p<0.001)

after 8 months [NRS]: mean ± SD

closure: 0.8 ± 0.2

non-closure: 0.8 ± 0.4

(p=NS)

course of pain

POD 1 [VAS]: mean ± SD

closure: 6.1 ± 1.8

non-closure: 4.5 ± 1.6

(p<0.01)

POD 15 [NRS]: mean ± SD

closure: 5.4  ± 1.7

non-closure: 3.5 ± 1.3

(p<0.01)

after 8 months [NRS]: mean ± SD

closure: 2.8 ± 1.5

non-closure: 1.7 ± 1.1

(p<0.01)

adverse effects/ events

not reported

 methodological shortcomings

– selective outcome reporting

level of evidence: 1

authors’ conclusion

“Parietal peritoneal closure during caesarean delivery contributes to a higher incidence of early and persistent postoperative pain. In this study, epigastric and global abdominal pain after caesarean delivery elicited the highest pain scores when the peritoneum was closed, and high scores on day 1 were predictors of persistent pain.”

 

reference participants’ characteristics intervention group/ control group

 

 outcomes critical appraisal/ conclusion
Mackeen 2012

Techniques and materials for skin closure in caesarean section.

 

Cochrane database of systematic reviews (Online), 2012. 11: p. CD003577

 databases/ search engines

– Medline

– Central

– Embase

– Cochrane Pregnancy and Childbirth Group’s Trials Register

– hand searches of 30 journals and proceedings of major conferences

search period

through 10.01.2012

inclusion criteria

– randomised controlled trials

– comparing different skin closure techniques and materials

exclusion criteria

– quasi randomised studies

included studies (n participants)

[1] Basha 2010 (430)

[2] Cromi 2010 (180)

[3] Frishman 1997 (66)

[4] Gaertner 2008 (153)

[5] Juergens 2011 (61)

[6] Murtha 2006 (195)

[7] Myers 2006 (114)

[8] Rengerink 2011 (132)

[9] Roungsipragarn 2001 (80)

[10] Rousseau 2009 (101)

[11] Tan 2008 (213)

 

 [1] Basha 2010

surgical staples versus 4-0 subcuticular poliglecaprone (Monocryl) suture

[2] Cromi 2010

surgical staples versus

absorbable 3-0 monofilament (Monosyn) versus

non-absorbable 3-0 monofilament made of polyamide fibres (Dafilon) versus

synthetic absorbable braided

suture made of low-molecular-weight polyglycolic acid (Safil Quick)

[3] Frishman 1997

staples versus 4-0 subcuticular polyglycolic acid suture

[4] Gaertner 2008

staples versus 3-0 subcuticular polyglactin (Vicryl rapide) suture, each of these 2 groups was further randomized to closure or non-closure of the subcutaneous space

[5] Juergens 2011

polyprophylene suture (Prolene) versus Leukosan SkinLink (adhesive coated, perforated, non-woven textile strips);

deep sutures placed in subcutaneous fat layer and subdermal suture placed

regardless of randomization group

[6] Murtha 2006

barbed suture versus 3-0 polydioxanone suture (PDS)

[7] Myers 2006

absorbable staples (INSORB) versus non-absorbable metal staples

[8] Rengerink 2011

staples versus 3-0 subcuticular poliglecaprone (Monocryl) suture; and closure versus non-closure of subcutaneous space

[9] Roungsipragarn 2001

2-0 polyglycolic acid suture versus transverse interrupted 0-nylon suture

[10] Rousseau 2009

surgical staples versus 4-0 subcuticular poliglecaprone (Monocryl) suture

[11] Tan 2008

absorbable monofilament poliglecaprone suture versus non-absorbable monofilament polypropylene suture

 Staples versus absorbable subcuticular suture

incisions closed with staples:

more likely to be complicated by separation: risk ratio (95% CI):

3.82 (2.05;7.12) [1-4,8]

required reclosure: risk ratio (95% CI)

4.98 (1.82;13.61) [1,4]

no differences in:

wound infection: risk ratio (95% CI)

0.85 (0.43;1.71) [1-4,8,10]

wound complications: risk ratio (95% CI)

1.52 (0.92;2.52) [1-4,8,10]

presence of haematoma: risk ratio (95% CI)

1.32 (0.10;18.39) [3,4,8]

presence of seroma: risk ratio (95% CI)

0.32 (0.01;7.68) [3,4]

readmission: risk ratio (95% CI)

0.56 (0.05;6.08) [1]

pain scale at discharge (10 cm scale): 3–4 days: MD (95% CI)

0.57 (-1.20;2.33) [3,10]

pain scale postpartum (10 cm): 6 weeks: MD (95% CI)

0.59 (-1.17; 2.36) [3,10]

cosmesis per physician (OSAS) at 2 months: MD (95% CI)

0.0 (-2.76;2.76) [2]

cosmesis per physician (OSAS) at 6 months: MD (95% CI)

1.69 (-0.44;3.83) [2,8]

cosmesis per patient (PSAS) at 2 months: MD (95% CI)

0.20 (-2.75;3.15) [2]

cosmesis per patient (PSAS) at 6 months: MD (95% CI)

0.75 (-2.08;3.59) [2,8]

patient satisfaction (10 cm scale): at discharge: MD (95% CI)

-0.80 (-1.85;0.25) [10]

patient satisfaction (10 cm scale): 6–8 weeks postoperatively: MD (95% CI)

0.12 (-1.24;1.49) [2,10]

patient satisfaction (10 cm scale): 6 months postoperatively MD (95% CI)

-0.5 (-1.17;0.17) [2]

total operative time (minutes): MD (95% CI)

-5.74 (-12.49;1.02) [2,10]

maternal length of stay (days): MD (95% CI)

0.10 [-0.01;0.21) [1]

presence of hypertrophic scar at 6 months: risk ratio (95% CI)

0.99 (0.58;1.70) [2]

staples versus absorbable subcuticular suture (sensitivity analysis)

no differences in:

wound infection: risk ratio (95% CI)

0.72 (0.17;3.01) [2,3,8,10]

wound complications: risk ratio (95% CI)

0.74 (0.19;2.85) [2,3,8,10]

presence of haematoma: risk ratio (95% CI)

0.33 (0.01;7.92) [3,8]

skin separation: risk ratio (95% CI)

3.78 (0.62;23.00) [2,3,8]

subcuticular suture versus interrupted suture

no difference in:

presence of hypertrophic scar at 6 months: risk ratio (95% CI)

1.85 (1.33;2.58) [9]

barbed suture versus PDS suture

wound infection: risk ratio (95% CI)

0.96 (0.18;5.10) [6]

wound complications: risk ratio (95% CI)

1.44 (0.30;6.93) [6]

seroma: risk ratio (95% CI)

2.42 (0.12;49.69) [6]

time to skin closure of dermal and epidermal layer (min): MD (95% CI)

0.60 (-0.30;1.50) [6]

 methodological shortcomings

– publication bias not assessed

– literature search not comprehensive

level of evidence: 1

authors’ conclusion

“There is currently no conclusive evidence about how the skin should be closed after caesarean section. Staples are associated with similar outcomes in terms of wound infection, pain and cosmesis compared with sutures, and these two are the most commonly studied methods for skin closure after caesarean section. If staples are removed on day three, there is an increased incidence of skin separation and the need for reclosure compared with absorbable sutures.”