Using rectal Methadone for pain management after spine surgery

Perioperative Rectal Methadone in Spine Surgery

This study is testing if using rectal Methadone can help adults manage pain better after spine surgery compared to a placebo.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Unity Health Toronto (other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06843174 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the feasibility of using rectal Methadone to manage postoperative pain in adult patients undergoing spinal surgery. Participants will be randomly assigned to receive either Methadone or a placebo during their surgery, with the primary focus on recruitment success and adherence. Secondary outcomes will assess pain intensity, opioid use, and recovery quality over a follow-up period of 30 days. The study aims to determine if rectal Methadone can effectively reduce pain and improve recovery compared to standard care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 undergoing elective spinal surgery with fusion.

Not a fit: Patients with severe comorbidities or contraindications to Methadone will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide an effective alternative for pain management in patients who cannot receive intravenous Methadone.

How similar studies have performed: While the use of Methadone for pain management is established, the specific approach of rectal administration in this context is novel and has not been widely tested.

Eligibility criteria

Inclusion Criteria:

1. 18 to 65 years-old.
2. Elective spinal surgery with fusion of one or more sacral, lumbar, thoracic, and/or cervical levels
3. Capacity to provide informed consent
4. For participants of childbearing potential, use of contraception.

Exclusion Criteria:

1. American Society of Anesthesiologists Physical Status \> IV
2. Hypersensitivity to the active substance (methadone hydrochloride) or other opioid analgesics 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, cor pulmonale, or pulmonary disease necessitating home oxygen therapy
6. Acute alcohol intoxication, delirium tremens, and convulsive disorders secondary to alcohol intoxication
7. Severe central nervous system depression, increased intracranial pressure, or head injury
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

Where this trial is running

Toronto, Ontario

• St. Michael's Hospital — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Sergio Pereira, MD PhD — St. Michael's Hospital. Unity Health Toronto
• Study coordinator: Sergio Pereira, MD PhD

Conditions: Spinal Surgery, Post-operative Care, Post-operative Pain Management, Intraoperative Methadone, Rectal Methadone administration, spinal surgery post-operative pain management