Parecoxib, celecoxib and paracetamol for pain management following caesarean delivery
In women receiving spinal anaesthesia for caesarean section, is there a difference in the opioid dose-sparing, analgesic efficacy and quality of post-operative pain relief provided by multimodal postoperative analgesic regimens based on patient controlled epidural analgesia (PCEA) with pethidine, together with either placebo, cyclo-oxygenase 2 enzyme (COX-2) inhibitors, paracetamol or COX-2 inhibitors and paracetamol in combination.
King Edward Memorial Hospital for Women
120 participants
Feb 18, 2010
Interventional
Conditions
Summary
This trial is investigating opioid dose-sparing, analgesic efficacy and quality of post-operative pain relief provided by multimodal analgesic regimens based on patient controlled epidural pethidine together with placebo, cyclo-oxygenase 2 enzyme (COX-2) inhibitors, paracetamol or COX-2 inhibitors and paracetamol in combination, in women receiving regional anaestheisa for elective caesarean section.
Eligibility
Inclusion Criteria2
- Elective caesarean section under combined spinal epidural anaesthesia
- American Society of Anesthesiologists classification 1 or 2
Exclusion Criteria9
- Pre-operative use of opioid medication
- Contraindication to combined spinal epidural anaesthesia
- Contraindication to parecoxib, celecoxib, paracetamol or tramadol
- Known intolerance or allergy to oxycodone, morphine, parecoxib, celecoxib or sulphonamides
- Pre-operative pruritus or nausea
- Failure to identify the subarachnoid space or to catheterise the epidural space at the time of combined spinal epidural anaesthesia
- Inadvertent dural puncture with the epidural needle or catheter
- Requirement for intra-operative opioid or epidural analgesics other than local anaesthetic
- Conversion to general anaesthesia
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Interventions
All women will receive patient-controlled epidural analgesia (PCEA) with pethidine (20 mg bolus, 15 minute lock-out, no background) and either: 1) placebo (intravenous normal saline 2 ml & normal saline 200 ml intra-operatively; oral placebo capsules - 2 capsules at 6 and 18 hours postoperatively & 4 capsules at 12 hours postoperatively) 2) cyclo-oxygenase 2 enzyme (COX-2) inhibitors (intravenous parecoxib 40 mg in 2 ml normal saline and placebo [normal saline 200 ml] intra-operatively; post-operatively, oral celecoxib 400 mg [2 x 200 mg capsules] at 12 hours postoperatively and 2 placebo capsules PO at 6, 12 and 18 hours) 3) intravenous paracetamol 2 g in 200 ml normal saline and intravenous normal saline 2 ml intra-operatively; post-operatively, oral paracetamol 1 g [2 x 500 mg capsules] at 6, 12 and 18 hours and 2 additional placebo capsules at 12 hours 4) COX-2 inhibitors and paracetamol in combination (intravenous parecoxib 40 mg in 2 ml normal saline and paracetamol 2 g in 200 ml normal saline intra-operatively; post-operatively, oral paracetamol 1 g [2 x 500 mg capsules] at 6, 12 and 18 hours and oral celecoxib 400 mg [2 x 200 mg capsules] at 12 hours) Intra-operative drugs will be given after delivery. All women will have access to rescue analgesia - immediate release oral tramadol 100 mg 2 hourly (maximum 600 mg in 24 hours). The placebo capsules are cornstarch in a gelatin capsule. The paracetamol 2 g in 200 ml normal saline or the placebo equivalent of 200 ml normal saline will be infused over 15 minutes. The parecoxib 40 mg in 2 ml normal saline or the placebo equivalent of 2 ml normal saline will be given as a bolus.
Locations(1)
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ACTRN12609001041246