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Perioperative Rectal Methadone in Spine Surgery

Study acronym: PROMISE
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 30, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Lead sponsor: Sergio to Unity Health Toronto Trial status: Not Yet Recruiting to Recruiting · Primary endpoints: 1 to 2 · Study sites: 0 to 1 · 2 morev2 Show 5 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoints: 1 to 2
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2025 to Feb 19, 2025
    • Secondary endpoints: 5 to 6

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06843174
Lead Sponsor Unity Health Toronto
Collaborators: AFP Innovation Fund
Conditions Spinal Surgery, Post-operative Care, Post-operative Pain Management
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov