Actively Recruiting
Perioperative Rectal Methadone in Spine Surgery
Led by Unity Health Toronto · Updated on 2025-03-30
40
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
Sponsors
U
Unity Health Toronto
Lead Sponsor
A
AFP Innovation Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Perioperative Rectal Methadone in Spine Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years
- Scheduled for elective spinal surgery with fusion of one or more sacral, lumbar, thoracic, or cervical levels
- Able to provide informed consent
- Using contraception if of childbearing potential
You will not qualify if you...
- American Society of Anesthesiologists Physical Status greater than IV
- Allergy or hypersensitivity to methadone, other opioids, or any ingredients in the formulation
- Pregnant or nursing
- Known or suspected mechanical gastrointestinal obstruction
- Acute respiratory depression, elevated carbon dioxide in blood, cor pulmonale, or pulmonary disease requiring home oxygen
- Acute alcohol intoxication, delirium tremens, or convulsive disorders from alcohol intoxication
- Severe central nervous system depression, increased intracranial pressure, or head injury
- Use of monoamine oxidase (MAO) inhibitors within 14 days before enrollment
- Diarrhea linked to pseudomembranous colitis from certain antibiotics
- Preoperative kidney failure or insufficiency
- Significant liver disease such as cirrhosis or hepatic failure
- Opioid use disorder within the last 3 months
- Taking more than 90 mg morphine equivalents daily
- Poor comprehension of English
- Likely to remain intubated after surgery
- QT interval over 500ms on preoperative ECG
AI-Screening
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Trial Site Locations
Total: 1 location
1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
Research Team
S
Sergio Pereira, MD PhD
CONTACT
J
Janneth A Pazmino-Canizares, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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