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NCT Number: NCT06843174

Perioperative Rectal Methadone in Spine Surgery

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.

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Key information

Conditions

Spinal Surgery Post-operative Care Post-operative Pain Management

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • American Society of Anesthesiologists Physical Status > IV
  • Hypersensitivity to the active substance (methadone hydrochloride) or other opioid analgesics or to any ingredient in the formulation
  • Pregnant or nursing participants
  • Known or suspected mechanical gastrointestinal obstruction
  • Acute respiratory depression, elevated carbon dioxide levels in the blood, cor pulmonale, or pulmonary disease necessitating home oxygen therapy
  • Acute alcohol intoxication, delirium tremens, and convulsive disorders secondary to alcohol intoxication
  • Severe central nervous system depression, increased intracranial pressure, or head injury
  • Use of monoamine oxidase (MAO) inhibitors, such as isocarboxazid, phenelzine, selegiline, and tranylcypromine, within 14 days of enrollment
  • Diarrhea associated with pseudomembranous colitis caused by cephalosporins, lincomycins, or penicillins
  • Preoperative renal insufficiency or failure
  • Significant liver disease (cirrhosis or hepatic failure)
  • History of opioid use disorder within the last 3 months
  • Patients taking more than 90 mg of morphine equivalents daily
  • Poor comprehension of the English language
  • Patients who are likely to remain intubated postoperatively
  • QT interval > 500ms on preoperative ECG

Treatment and study plan

Rectal Methadone administer during spinal surgery

Drug

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

Placebo: Rectal saline solution

Other

Placebo: Rectal saline solution single dose received during surgery

Primary outcomes

  1. Feasibility to recruit 40 participants into a trial of methadone and placebo

    Time frame: 18 months

    Recruitment rate (Acceptability and feasibility study)

  2. Feasibility to recruit 40 participants into a trial of methadone and placebo

    Time frame: 18 months

    Withdrawal rate (Acceptability and feasibility study)

Secondary outcomes

  1. Adverse outcomes

    Time frame: At 24, 48, and 72 hours post operative

    Rate of postoperative respiratory depression

  2. Adverse outcomes

    Time frame: At 24, 48, and 72 hours post operative

    Rate of postoperative ileus

  3. Opioid reduction

    Time frame: At 24, 48, and 72 hours post operative

    Total morphine equivalent used

  4. Pain intensity after surgery

    Time frame: At 24, 48, and 72 hours post operative

    Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS) Pain Intensity, Pain intensity scale- 0 to 10 (The higher the number the higher the pain intensity)

  5. Quality of Recovery

    Time frame: At 24, 48, and 72 hours post operative

    Quality of Recovery (QoR-15) Score, 15 items are rated on a 0-10 scale, with the total possible score ranging from 0 to 150, where higher scores indicate better recovery.

  6. Pain interference

    Time frame: Difference between Baseline and 30 days after surgery

    Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. 6 items, 5 Likert scale (the higher the score the higher the interference from pain)

Study contacts

Contact information is provided by the study sponsor or research team.

Janneth A Pazmino-Canizares, MSc

CONTACT

[email protected]

4168646060 ext. 49561

Sergio Pereira, MD PhD

CONTACT

[email protected]

416-360-4000 ext. 49308

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • AFP Innovation Fund

Registry information

Acronym: PROMISE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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