Recruiting

Methadone

Sponsor:

Unity Health Toronto

Code:

NCT06843174

Conditions

Spinal Surgery

Post-operative Care

Post-operative Pain Management

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Rectal Methadone administer during spinal surgery

Placebo: Rectal saline solution

Study Details

Brief 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

Study ID

NCT06843174

Start date

Feb 19, 2025

Status verified date

Mar, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention Arm with Methadone

During the spinal surgery intervention, participants receive a single dose of 0.2mg/kg of Methadone rectally, after anesthesia induction.

placebo comparator: Placebo arm

During the spinal surgery intervention, participants receive a single dose of saline solution rectally after anesthesia induction.

Interventions

Rectal Methadone administer during spinal surgery

Rectal Methadone administered during spinal surgery for post-operative pain management

Placebo: Rectal saline solution

Placebo: Rectal saline solution single dose received during surgery

Primary outcome measure

  • Feasibility to recruit 40 participants into a trial of methadone and placebo [ Time Frame: 18 months ]
  • Feasibility to recruit 40 participants into a trial of methadone and placebo [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Sergio Pereira, MD PhD

416-360-4000Sergio.Pereira@unityhealth.to

Janneth A Pazmino-Canizares, MSc

4168646060Janneth.Pazmino-Canizares@unityhealth.to

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Sergio Pereira, MD. PhD

416-360-4000sergio.pereira@unityhealth.to

Janneth Pazmino-Canizares, MSc

4168646060Janneth.Pazmino-Canizares@unityhealth.to

More Information

Sponsor

Unity Health Toronto

Last update posted

Mar 30, 2025

Last verified

Mar, 2025

Keywords

  • Intraoperative Methadone
  • Rectal Methadone administration
  • spinal surgery post-operative pain management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2025-03-30.