None listed
Conditions
Brief 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.
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.
Sponsors
Study design
Eligibility
Inclusion criteria
Elective caesarean section under combined spinal epidural anaesthesia American Society of Anesthesiologists classification 1 or 2
Exclusion criteria
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