RecruitingPhase 4NCT06843174

Perioperative Rectal Methadone in Spine Surgery


Sponsor

Unity Health Toronto

Enrollment

40 participants

Start Date

Feb 19, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo: Rectal saline solution and a drug called Rectal Methadone administer during spinal surgery for people with post-operative pain management, post-operative care, and other related conditions. The study is currently recruiting participants at 1 location.

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.

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Interventions

DRUGRectal Methadone administer during spinal surgery

Rectal Methadone administered during spinal surgery for post-operative pain management

OTHERPlacebo: Rectal saline solution

Placebo: Rectal saline solution single dose received during surgery


Locations(1)

St. Michael's Hospital

Toronto, Ontario, Canada

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NCT06843174


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