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RECRUITING
NCT06843174
PHASE4

Perioperative Rectal Methadone in Spine Surgery

Sponsor: Unity Health Toronto

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-02-19

Completion Date

2026-08

Last Updated

2025-03-30

Healthy Volunteers

No

Interventions

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

Locations (1)

St. Michael's Hospital

Toronto, Ontario, Canada