Perioperative Rectal Methadone in Spine Surgery

Last updated: March 25, 2025
Sponsor: Unity Health Toronto
Overall Status: Active - Recruiting

Phase

4

Condition

Spinal Surgery

Treatment

Rectal Methadone administer during spinal surgery

Placebo: Rectal saline solution

Clinical Study ID

NCT06843174
P-004
  • Ages 18-65
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 to 65 years-old.

  2. Elective spinal surgery with fusion of one or more sacral, lumbar, thoracic, and/orcervical levels

  3. Capacity to provide informed consent

  4. For participants of childbearing potential, use of contraception.

Exclusion

Exclusion Criteria:

  1. American Society of Anesthesiologists Physical Status > IV

  2. Hypersensitivity to the active substance (methadone hydrochloride) or other opioidanalgesics or to any ingredient in the formulation

  3. Pregnant or nursing participants

  4. Known or suspected mechanical gastrointestinal obstruction

  5. Acute respiratory depression, elevated carbon dioxide levels in the blood, corpulmonale, or pulmonary disease necessitating home oxygen therapy

  6. Acute alcohol intoxication, delirium tremens, and convulsive disorders secondary toalcohol intoxication

  7. Severe central nervous system depression, increased intracranial pressure, or headinjury

  8. Use of monoamine oxidase (MAO) inhibitors, such as isocarboxazid, phenelzine,selegiline, and tranylcypromine, within 14 days of enrollment

  9. Diarrhea associated with pseudomembranous colitis caused by cephalosporins,lincomycins, or penicillins

  10. Preoperative renal insufficiency or failure

  11. Significant liver disease (cirrhosis or hepatic failure)

  12. History of opioid use disorder within the last 3 months

  13. Patients taking more than 90 mg of morphine equivalents daily

  14. Poor comprehension of the English language

  15. Patients who are likely to remain intubated postoperatively

  16. QT interval > 500ms on preoperative ECG

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Rectal Methadone administer during spinal surgery
Phase: 4
Study Start date:
February 19, 2025
Estimated Completion Date:
August 31, 2026

Study Description

Indication: Adult patients undergoing spine surgery Condition: Perioperative pain management Number of participants 40 Primary outcome Feasibility (recruitment success, consent rate, adherence, patient withdrawal, missing data, adverse outcomes) Secondary outcome 1) Average pain intensity; 2) Rate of respiratory depression and postoperative ileus; 3) Use of opioids in morphine equivalents; 4) Quality of recovery Study design

  • Interventional trial

  • Allocation: Randomized

  • Intervention model: 2-Arm Parallel-Group

  • Primary purpose: Feasibility

  • Phase: Phase IV

Masking Participants and Outcome Assessors

Study Intervention:

  • Intervention Arm: Methadone 0.2mg/kg of ideal body weight via rectal administration

    • standard or care

  • Placebo Arm: Saline solution via rectal administration + standard of care

Follow-Up: Postoperative days 1, 2, 3, and 30

Connect with a study center

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

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