CompletedPhase 4ACTRN12609001041246

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.


Sponsor

King Edward Memorial Hospital for Women

Enrollment

120 participants

Start Date

Feb 18, 2010

Study Type

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

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares different pain relief combinations after a planned cesarean section delivery to find which best manages post-operative pain. Women aged 18 and over having an elective cesarean under spinal-epidural anesthesia who are not already taking opioid pain medication may participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 sal

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)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12609001041246