A prospective, randomized, double-blind, placebo-controlled trial of multimodal intraoperative analgesia for laparoscopic excision of endometriosis

Abstract

Objective: To assess the efficacy of multimodal intraoperative analgesia in reducing postoperative pain and/or opioid requirements in women undergoing laparoscopic excision of endometriosis.

Design: Prospective, randomized, double-blind, placebo-controlled trial.

Setting: Endogynecologic department of a university teaching hospital.

Patient(s): Women booked for laparoscopic excision of endometriosis.

Intervention(s): Intraoperative multimodal analgesia versus placebo. Analgesia consisted of Diclofenac sodium 100 mg suppository per rectum and 0.75% Ropivacaine to portal sites, subperitoneally under excision sites and topically to each subdiaphragmatic area.

Main outcome measure(s): Postoperative total hospital opioid analgesic requirements and postoperative pain intensity.

Result(s): The study was terminated prematurely, after a planned interim analysis (which included 66 randomized patients or 43% of the planned number of patients) found significantly less total hospital opioid requirements in the analgesic group compared with the placebo group (19.0 mg vs. 34.5 mg; difference -14.0 mg [95% confidence interval -26.0 to -2.0 mg]). There was no difference in postoperative pain intensity between the two groups.

Conclusion(s): The use of multimodal intraoperative analgesia at laparoscopic excision of endometriosis reduces postoperative opioid requirements.