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Methadone for Post-operative Spine Surgery

NCT07517679 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-20

No results posted yet for this study

Summary

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.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Methadone

Methadone 0.2 mg/kg (max 20 mg)

DRUG

Standard of care

Standard intraoperative opioid regimen (control)

Sponsors & Collaborators

  • Brandon Knopp

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-10
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07517679 on ClinicalTrials.gov