Methadone for Post-operative Spine Surgery

NCT07517679 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 111197
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

methadone; opioids; spine surgery

Outcome Measures

Primary Outcomes (1)

• Perioperative Opioid use in morphine equivalents (ME)

  perioperative opioid use (morphine equivalents (ME): intraoperative, PACU, and 72-hour totals)

  Perioperative until 72 hours postoperative

Secondary Outcomes (6)

• Change in numeric rating scale (NRS) pain scores

  PACU arrival to 24 hours postoperative

• Time in PACU

  PACU arrival to PACU discharge (determined by time of PACU discharge note entry). Assess up to 24 hours postoperatively.

• Hospital Length of Stay

  Hospital admission to hospital discharge. Measured in days and determined as the time from admission for surgery to hospital discharge. Assess up to 30 days postoperatively

• Incidence of respiratory depression

  Measured from time of PACU admission until 72 hours postoperatively.

• Incidence of Postoperative nausea and vomiting

  Assessed postoperatively up to 72 hours after documented PACU admission time

Study Arms (2)

Methadone

EXPERIMENTAL

Drug: Methadone

Standard of care

ACTIVE COMPARATOR

Drug: Standard of care

Interventions

Methadone DRUG

Methadone 0.2 mg/kg (max 20 mg)

Methadone

Standard of care DRUG

Standard intraoperative opioid regimen (control)

Standard of care

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brandon Knopp: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methadone; Standard of Care

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)