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Perioperative Rectal Methadone in Spine Surgery

NCT06843174 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

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

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

Sponsors & Collaborators

  • AFP Innovation Fund

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Sergio Pereira, MD PhD · St. Michael's Hospital. Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-19
Primary Completion
2026-07-31
Completion
2026-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06843174 on ClinicalTrials.gov