Recruiting

Methadone

Sponsor:

Brandon Knopp

Code:

NCT07517679

Conditions

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Methadone

Standard of care

Study Details

Brief 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

Study ID

NCT07517679

Start date

Jun 10, 2026

Status verified date

Jun, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Undergoing elective spine surgery (e.g., fusion, decompression)
  • Expected postoperative inpatient admission
  • Able to provide informed consent
  • Patients with opioid use disorder (OUD) may be included if on stable maintenance therapy

Exclusion Criteria:

  • Use of regional or neuraxial anesthesia
  • Contraindication to methadone use (e.g., prolonged QTc, allergy, severe hepatic disease)
  • Cognitive impairment precluding consent or accurate pain scoring

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Methadone

active comparator: Standard of care

Interventions

Methadone

Methadone 0.2 mg/kg (max 20 mg)

Standard of care

Standard intraoperative opioid regimen (control)

Primary outcome measure

  • Perioperative Opioid use in morphine equivalents (ME) [ Time Frame: Perioperative until 72 hours postoperative ]

Central Contacts and Locations

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

More Information

Sponsor

Brandon Knopp

Last update posted

Jul 20, 2026

Last verified

Jun, 2026

Keywords

  • methadone
  • opioids
  • spine surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brandon Knopp on 2026-07-20.