Health TrialsbyHealthPanel

Perioperative Rectal Methadone in Spine Surgery

ConditionsSpinal SurgeryPost-operative CarePost-operative Pain Management
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUnity Health Toronto

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rectal Methadone administer during spinal surgery

    Drug

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

  • Placebo: Rectal saline solution

    Other intervention

    Placebo: Rectal saline solution single dose received during surgery

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intervention Arm with MethadoneExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Recruitment rate (Acceptability and feasibility study)

Time frame
18 months
2

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

Withdrawal rate (Acceptability and feasibility study)

Time frame
18 months

Secondary outcomes

1

Adverse outcomes

Rate of postoperative respiratory depression

Time frame
At 24, 48, and 72 hours post operative
2

Adverse outcomes

Rate of postoperative ileus

Time frame
At 24, 48, and 72 hours post operative
3

Opioid reduction

Total morphine equivalent used

Time frame
At 24, 48, and 72 hours post operative
4

Pain intensity after surgery

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)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Unity Health Toronto

Lead sponsor

AFP Innovation Fund

Collaborator

Source ClinicalTrials.gov
Apply now