Perioperative Rectal Methadone in Spine Surgery for Post-Operative Pain Management

What this Trial Is About

Researchers are evaluating whether rectal administration of Methadone can help manage pain after spinal surgery. This pilot trial focuses on adult patients undergoing elective spinal fusion surgery and compares Methadone to a placebo to assess feasibility, pain control, medication use, and recovery quality. The study also aims to determine if recruiting participants for a larger trial is possible. It is a randomized, phase IV clinical trial conducted by Unity Health Toronto. Participants receive a single dose of Methadone at 0.2 mg/kg of ideal body weight or a saline placebo rectally during surgery after anesthesia induction. Both groups receive standard care alongside the study intervention. The trial has two arms: one with Methadone and one with placebo, and participants and outcome assessors are blinded to treatment allocation. Follow-up occurs on postoperative days 1, 2, 3, and 30 to monitor outcomes. During the study, participants will be asked about their pain levels from days 1 to 3 after surgery and contacted by phone about their recovery at day 30. Researchers will monitor feasibility measures like recruitment success, consent rates, adherence, patient withdrawal, missing data, and adverse events. Secondary outcomes include pain intensity, opioid use, respiratory depression, postoperative ileus, quality of recovery, and pain interference. The trial plans to recruit 40 participants and will last up to 18 months from initiation to completion.

Perioperative Rectal Methadone in Spine Surgery