Methadone for Postoperative Pain

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Brandon Knopp
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this prospective cohort study is to evaluate the clinical effects of post-induction methadone on perioperative pain control, opioid requirements, and recovery outcomes in adult patients undergoing elective spine surgery, with the goal of improving postoperative analgesia and enhancing recovery efficiency. The main questions it aims to answer are the perioperative pain control and opioid requirements between the two groups.

Post-induction methadone can offer equivalent or improved pain control following major spine procedures and reduce intra- and postoperative opioid requirements, improve perioperative pain control and shorten PACU stay.

Researchers will compare perioperative opioid use (morphine equivalents (ME), during the intraoperative and postoperative periods (PACU and 24-hour totals) between the standard intraoperative opioid regimen group and the methadone group.

Patients will be randomized preoperatively to one of two groups: (both groups will receive additional multimodal pain control including opioids, not including methadone, as needed) Standard intraoperative opioid regimen (control) Methadone 0.2 mg/kg (max 20 mg)

If the patient is in the methadone group, the patient will receive a predetermined dose of Methadone (0.2mg/kg) intravenously after induction (they are given medications to sleep for surgery). They will proceed with surgery, and all patients will receive standard of care management regardless of whether they receive Methadone or not. Following the surgery, all study participants will be asked at set times about their pain level and, 24 hours after the surgery, will be asked if they are satisfied with their pain management for the surgery. Data regarding their clinical progression and pain control/pain medication requirements will be collected for the duration of the hospitalization.

Are You a Good Fit for This Trial?

Inclusion Criteria

* Patients with opioid use disorder (OUD) may be included if on stable maintenance therapy
I am scheduled for elective spine surgery.
* Expected postoperative inpatient admission
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either standard intraoperative opioid regimen or methadone post-induction during spine surgery

Perioperative period
1 visit (in-person, surgery day)

Postoperative Monitoring

Participants are monitored for pain control, opioid use, and recovery outcomes including respiratory depression and nausea

72 hours
Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including patient satisfaction and hospital length of stay

Up to 30 days

What Are the Treatments Tested in This Trial?

Interventions

  • Methadone

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: MethadoneExperimental Treatment1 Intervention
Group II: Standard of careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brandon Knopp

Lead Sponsor