NCT06843174

Perioperative Rectal Methadone in Spine Surgery

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Patients undergoing spinal surgery require pain control medication after their surgery. Investigators have successfully used intravenous Methadone to manage pain after surgery. However, doctors in Canada do not have the intravenous form of Methadone to prescribe to their patients. The investigators in Canada propose a pilot trial to investigate whether Methadone administered rectally could be used to manage pain after spinal surgery. The main questions are: 1. Are investigators able to recruit participants for this trial and learn from this study to plan a larger trial? 2. Does Methadone administered rectally during surgery, reduce participants' pain intensity, use less pain medication, and have a better recovery after surgery? Investigators will compare Methadone to a placebo (a look-alike substance that contains no drug) to see if Methadone works to manage pain after surgery better than the usual pain management. Participants will: * receive either Methadone or placebo during surgery. * be asked some questions about their pain during days 1 to 3 after surgery * be contacted by phone to ask about their recovery At this time, the study aims to recruit 40 participants from St. Michael's Hospital, to learn whether it will be feasible to plan a larger study.

Detailed description

Indication: Adult patients undergoing spine surgery Condition: Perioperative pain management Number of participants 40 Primary outcome Feasibility (recruitment success, consent rate, adherence, patient withdrawal, missing data, adverse outcomes) Secondary outcome 1) Average pain intensity; 2) Rate of respiratory depression and postoperative ileus; 3) Use of opioids in morphine equivalents; 4) Quality of recovery Study design * Interventional trial * Allocation: Randomized * Intervention model: 2-Arm Parallel-Group * Primary purpose: Feasibility * Phase: Phase IV Masking Participants and Outcome Assessors Study Intervention: * Intervention Arm: Methadone 0.2mg/kg of ideal body weight via rectal administration + standard or care * Placebo Arm: Saline solution via rectal administration + standard of care Follow-Up: Postoperative days 1, 2, 3, and 30

Conditions

• Spinal Surgery
• Post-operative Care
• Post-operative Pain Management

Interventions

Type	Name	Description
DRUG	Rectal Methadone administer during spinal surgery	Rectal Methadone administered during spinal surgery for post-operative pain management
OTHER	Placebo: Rectal saline solution	Placebo: Rectal saline solution single dose received during surgery

Timeline

• Start date: 2025-02-19
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2025-02-24
• Last updated: 2025-03-30

Locations

1 site across 1 country: Canada