The effect of gabapentin versus intrathecal fentanyl on postoperative pain and morphine consumption in cesarean delivery: a prospective, randomized, double-blind study.
Archives of Gynecology and Obstetrics, 2014: p. 1-6.
– ASA physical status I/II
– spinal anaesthesia
exclusion criteria
– contraindications to neuraxial anaesthesia or to any study medication, smoking, hepatitis, chronic use of gabapentin or opioid
– psychological problem,
– severe preeclampsia
– known fetus abnormality
– diabetic mellitus
demographic data:
no significant differences in baseline characteristics
maternal age [yr.]: mean ± SD
group G: 27 ± 4
group F: 28 ± 4
maternal weight [kg]: mean ± SD
group G: 78 ± 14
group F: 79 ± 13
BMI [kg/m2]: mean ± SD
group G: 29 ± 3
group F: 28 ± 3
gestational age [wk.]: mean ± SD
group G: 37.3 ± 1.3
group F: 37.5 ± 1.1
patient flow and follow up:
total patient number included:
78
randomised in:
group G: 39
group F: 39
excluded: 1
group G
failure of spinal block: 1
analysed:
group G: 38
follow-up:
24 hours
intravenous lactated Ringer’s solution 8 mL/kg
mode of anaesthesia
SpA
group G:
0.5% heavy bupivacaine 12.5 mg IT
gabapentin 300 mg PO 2 h before surgery
group F:
0.5% heavy bupivacaine 12.5 mg plus fentanyl 10 µg IT plus placebo capsule
surgical approach
not reported
hypotension
treated with 5–10 mg of ephedrine IV
after delivery IV syntocinon 15 U diluted in 1 L Ringer’s lactate solution
at the end of surgery
clindamycin 600 mg IV and diclofenac 100 mg rectally
supplemental analgesia
morphine via iPCA (dose 1 mg, lockout 5 min, </=10 mg/24h)
rescue analgesia
first day of surgery
diclofenac 100 mg rectally and morphine 2 mg subcutaneously every 6 h as requested
afterwards
morphine could be substituted with paracetamol 1 g PO and diclofenac 100 mg rectally every 8 h as requested
group G: 4.59 ± 1.63
group F: 2.65 ± 0.92
(p<0.0001)
total dosage of morphine in 24 h [mg]: mean ± SD
group G: 7.18 ± 3.26
group F: 12.62 ± 5.16
postoperative pain [VAS]: mean (95% CI)
group G: 24 (13–30)
group F: 38 (24–56)
(p=0.001)
Apgar score: median (range)
group G group F
min 1 10 (7–10) 10 (7–10)
min 2 10 (9–10) 10 (9–10)
(p=NS)
patients satisfaction: median (range)
group G: 7 (4–10)
group F: 5 (1–9)
(p=0.0001)
adverse effects/ events: n (%)
vomiting 4 (10.26) 5 (12.82)
shivering 9 (23.08) 7 (17.95)
pruritus 0 (0) 0 (0)
sedation score
higher in group G
(p=0.012)
– allocation concealment not reported
– blinding of outcome assessor not reported
– no sample size calculation
level of evidence: 1
authors’ conclusion
“…Pre-emptive use of gabapentin is a safe way to reduce postoperative pain and morphine consumption in parturient after caesarean surgery and can be a substitute for intrathecal opioid especially in patients who are sensitive to side effect of opioids.”
Gabapentin improves postcesarean delivery pain management: A randomized, placebo-controlled trial
International Anesthesia Research Society, 2011. 112: p. 167-174
– full-term pregnancy
– >/=18 years old
– moderate to severe systematic illness
– ASA physical status >/=3
– any contraindications to neuraxial anaesthesia or any of the study medications
– infectious diseases (e.g. human immunodeficiency virus, hepatitis)
– uncontrolled hypertension or diabetes mellitus
– known IV drug users – fetuses having known congenital abnormalities
– women who had taken pain medication in the past week
demographic data
maternal age [yr]: mean ± SD
group G: 35 ± 5
group P: 34 ± 6
BMI: mean ± SD group G: 29 ± 4
group P: 30 ± 6
gestational age (weeks):mean ± SD
group G: 38.8 ± 0.7
group P: 38.9 ± 0.8
parity median (range)
group G: 1 (0–6) group P: 1 (0–6)
repeat caesarean delivery [n (%)]
group G: 18 (86)
group P: 15 (65)
patient flow and follow up
46
group G: 23
group P: 23
excluded: 2
group G: 2 – patient underwent successful version and did not undergo caesarean delivery (n=1)
– patient unblinded due to hypoglycaemia/sedation (n=1)
analysed: 44
G: 21
P: 23
follow up:
3 months (n=36)
oral gabapentin 600 mg 1 h before surgery group P: oral lactose placebo
all patients: 10 mL/kg of Ringer‘s lactate solution
SpA: 0.75% hyperbaric bupivacaine 12 mg, fentanyl 10 µg and morphine 100 µg
surgical approach not reported.
intraoperative pain management
– IV fentanyl </=100 µg
at end of surgery
IV ketorolac 30 mg IV and
rectal acetaminophen 1 g
postoperative pain management
in PACU:
IV morphine 2 mg every 5 min upon patient request
on the ward:
oral diclofenac 50 mg every 8 h and oral acetaminophen 1 g every 6 h for 72 h
SC morphine 2 mg every 4 h for first 24 h, and then
oral morphine 5 mg every 4 h
at rest
significantly lower in group G at 6 and 12 h, but not at 24 and 48 h
on movement
significantly lower in group G at 6, 12, 24 and 48 h
need for supplemental morphine: n, mean [mg] (95% CI)
</=24 h
group G: 5, 3.2 (1.0–5.4)
group P: 5, 4.2 (1.1–7.2)
24–48 h
group G: 3, 5 (5–5)
group P: 3, 8 (5–10)
at 1 min
group G: 9 (8–9)
group P: 9 (8–9)
at 5 min
group G: 9 (9–9)
group P: 9 (9–9)
adverse effects/ events:
no significant differences in:
– nausea
– vomiting
– pruritus
severe sedation
(p=0.04)
at 3 months after delivery
– persistent pain
– abnormal sensation at the incision site
– pain limiting daily functions
– use of medications for pain at the incision site
– number of patients still breastfeeding
no methodological shortcomings according to evaluation sheet
authors’ conclusion: “…a single dose of 600 mg of oral gabapentin, given preoperatively, significantly decreases acute postcesarean delivery pain and increases patient satisfaction.
Gabapentin in this dosage increases maternal sedation; however, it does not adversely affect the neonate.”
A single preoperative dose of gabapentin does not improve postcesarean delivery pain management: A randomized, double-blind, placebo-controlled dose-finding trial
Anaesthesia and Analgesia 2012, Vol 116 (6), p. 1336- 1342
– singleton term pregnancy
– contraindication to neuraxial anaesthesia or to any study medication used
– history of epilepsy, central nervous system or mental disorders
– chronic pain, drug abuse, use of neuropathic analgesic or antiepileptic drugs
– fetus with known congenital abnormalities
G600: 34.8 ± 4.1
G300: 35.1 ± 3.8
P: 35.2 ± 4.8
BMI: mean ± SD G600: 30.6 ± 5.6
G300: 30.1 ± 3.7
P: 29.3 ± 4.3
gravity median [range]
G600: 2 [1–6]
G300: 2 [1–5]
P: 3 [1–10]
parity median [range]
G600: 1 [0–3]
G300: 1 [0–3]
P: 1 [0–3]
primary caesarean delivery (n)
G600: 12
G300: 12
P: 9
repeat caesarean delivery (n)
G600: 30
G300: 30
P: 33
132
G600: 44
G300: 44
P: 44
excluded:
group G300:
– n=1 postponed
– n=1 failed spinal
Group G600:
– n=1 protocol breach
Group P: – n=1 protocol breach
analysed: 126
group 300: 42
group 600: 42
group P: 42
48 hours (n=126) 3 month (n=112)
Group 300:
– 300 mg gabapentin PO
Group 600: – 600 mg gabapentin PO
Group P: – placebo (lactose) PO
prior to anaesthesia
– 10 mL/kg Ringer’s lactate solution with antibiotic prophylaxis (not specified)
anaesthesia
-SpA: 0.75% hyperbaric bupivacaine 13.5 mg
– 10 µg fentanyl
– 100 µg preservative-free morphine
– IV fentanyl at the discretion of the anaesthesiologist
after cord clamping
– oxytocin IV 20 IU over 8 h
at the end of surgery: – 30 mg ketorolac IV and 1300 mg acetaminophen rectally
– 2 mg IV morphine at 5-min intervals on request
– 50 mg diclofenac PO every 8 h and 1g acetaminophen every 6 h for 72 h
</=24 h:
2 mg subcutaneous morphine on request
>24 h:
10 mg oral morphine on request
no significant differences between the three groups
on moving
– supplemental parenteral morphine </=24 h
(p=0.14)
– morphine dose </=24 h
(p=0.46)
– supplemental oral morphine >24 h
(p=0.58)
– morphine dose >24 h
(p=0.18)
no significant differences between the three groups at 1 and 5 min
– sedation
– outcome assessors not blinded
“…a single preoperative dose of 300 mg or 600 mg gabapentin did not improve postcesarean pain management and maternal satisfaction in the context of multimodal analgesic regimen inclusive of intrathecal morphine. The study was however underpowered to allow any definitive conclusion….”
Effect of dexamethasone on prevention of postoperative nausea, vomiting and pain after caesarean section: a randomised, placebo-controlled, double-blind trial.
Eur J Anaesthesiol, 2013. 30(3): p. 102-5.
– ASA physical status I/ II
– first procedure of the day
– any contraindication to regional anaesthesia
– allergic to dexamethasone, to opioids or local anaesthetics
– pregnancy induced hypertension or diabetes
– any antiemetic drug in the 24 h prior to surgery
no significant differences
group D: 28.2 ± 5.4
group P: 26.1 ± 5.3
group D: 86.0 ± 6.3
group P: 86.0 ± 6.5
maternal height [kg]: mean ± SD
group D: 166.1 ± 3.9
group P: 165.8 ± 3.4
smoker: n
group D: 7
group P: 8
70
group D: 35
group P: 35
0
all randomised patients analysed
group D:
IV dexamethasone 10 mg
group P:
IV 0.9% saline
SpA: hyperbaric bupivacaine 15 mg and morphine 60 µg
after delivery
IV ketoprofen 100 mg, IV dipyrone 2 g and IV oxytocin 15 IU
6 h after delivery
PO diclofenac 75 mg every 8h and dipyrone 2 g every 6h
if VAS>3 or requested by patient:
tramadol 100 mg infused over 20 min
at rest: n (%)
group D group P p-value
at 1 h 3 (9) 9 (26) NS
at 2 h 4 (11) 11 (31) NS
at 3 h 6 (17) 14 (41) NS
at 6 h 2 (6) 12 (34) 0.005
at 12 h 4 (11) 10 (29) NS
at 24 h 5 (14) 10 (29) NS
with movement: n (%)
at 1 h 5 (14) 15 (43) 0.001
at 2 h 6 (17) 14 (41) NS
at 6 h 4 (11) 16 (46) 0.003
at 12 h 4 (11) 15 (43) 0.006
at 24 h 5 (14) 15 (43) 0.01
adverse effects/ events
nausea: n
PACU (0-3 h) 11 26 <0.001
ward (3-24 h) 1 6 NS
total (0-24 h) 12 32 <0.001
nausea: n (%)
at 1 h 6 (17) 11 (31) NS
at 2 h 4 (11) 9 (26) NS
at 3 h 1 (3) 6 (17) NS
at 6 h 1 (23) 2 (6) NS
at 12 h 0 2 (6) NS
at 24 h 0 2 (6) NS
vomiting: n
PACU (0–3 h) 11 23 <0.01
ward (3–24 h) 1 6 NS
total (0–24 h) 12 29 <0.001
vomiting: n (%)
at 2 h 4 (11) 6 (17) NS
at 6 h 1 (3) 2 (6) NS
“…although we observed a trend towards a lower incidence of postoperative nausea and vomiting in the dexamethasone group, this effect was significant only when considering the cumulative incidence. It was also associated with reduced pain scores during the first postoperative day”
Prevention of postoperative nausea and vomiting after intrathecal morphine for cesarean section: a randomized comparison of dexamethasone, droperidol, and a combination
International Journal of Obstetric Anesthesia 16(2): 122-127.
– allergic to dexamethasone, droperidol, opioids, or local anaesthetics
– established hypertension or glucose intolerance; gastrointestinal
– disease and administration of antiemetic medication in the previous 24 h
group Dex: 30 ± 5.2
group Dro: 28 ± 5.3
group Dex+Dro: 29 ± 4.8
group P 29 ± 4.3
group Dex: 71 ± 9.2
group Dro: 70 ± 9.7
group Dex+Dro: 71 ± 8.3
group P 69 ± 8.8
group Dex: 161 ± 5.5
group Dro: 159 ± 5.1
group Dex+Dro: 160 ± 5.3
group P 160 ± 5.2
parity: nulliparous n (%)/ multiparous n (%)
group Dex: 16 (54)/ 14 (46)
group Dro: 14 (46)/ 16 (54)
group Dex+Dro: 14 (46)/ 16 (54)
group P: 13 (43)/ 17 (57)
120
group Dex: 30
group Dro: 30
group Dex+Dro: 30
group P 30
SpA: 0.5% hyperbaric bupivacaine 10 mg and morphine 0.2 mg
group Dex
IV dexamethasone 8 mg before skin incision and saline 2 mL after clamping the cord
group Dro
IV saline before skin incision and IV droperidol 1.25 mg after clamping the cord
group Dex+Dro
IV dexamethasone 4 mg before skin incision and IV droperidol 0.625 mg after clamping the cord
group P
IV normal saline 2 mL before skin incision and after clamping of cord
If VAS >3 or patients requested:
IM diclofenac 75 mg.
0–3 h at rest
group Dex: 0.1 (0–2)
group Dro: 0.1 (0–1)
group Dex+Dro: 0.1 (0–1)
group P: 0.1 (0–1)
3–6 h at rest
group Dro: 0.3 (0–2)
group Dex+Dro: 0.2 (0–2)
group P: 0.4 (0–4)
6–24 h at rest
group Dex: 0.4 (0–2)
group Dro: 1.6 (0–4)*
group Dex+Dro: 1.3 (0–4)*
group P: 1.7 (0–6)*
*p<0.05 versus group Dex
0–3 h at movement
group Dex: 0.7 (0–4)
group Dro: 0.7 (0–2)
group P: 0.8 (0–4)
3–6 h at movement
group Dex: 1.1 (0–4)
group Dro: 1.2 (0–5)
group Dex+Dro: 0.6 (0–2)
group P: 0.7 (0–6)
6–24 h at movement
group Dex: 2.3 (0–4)
group Dro: 3.4 (2–6)*
group Dex+Dro: 2.6 (1–6)
group P: 3.3 (2–5)*
need for supplemental analgesia
group Dex: 3
group Dro: 6
group Dex+Dro: 3
group P: 5
PONV
first 6 h: groups Dro and Dex+Dro significantly lower incidence of PONV than group Dex and P
significantly more patients in group Dex+Dro complete response (no PONV for 24 h) than in groups Dex and P
no significant differences between groups Dro and Dex+Dro in incidence of PONV 24 h postoperatively and the number of complete responses.
sedation
significantly higher in group Dro than in the other three groups during =3 h, but not thereafter
no differences among groups in
– wound infections
– delayed wound healing
“…combination of dexamethasone 4 mg and droperidol 0.625 mg provides an additive antiemetic effect with a low incidence of adverse effects.
This combination proved more effective for prevention of PONV following spinal anesthesia with 0.5% bupivacaine and morphine 0.2 mg than dexamethasone 8 mg or droperidol 1.25 mg alone.”
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