Methadone for Post-operative Spine Surgery

Effect of Post-Induction Methadone on Postoperative Pain, Opioid Use, and Recovery in Spine Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Methadone; Drug: Standard of care

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky
      • Contact: Brandon Knopp, MD; Phone Number: 859-218-0097; Email: bwkn222@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care	Drug: Standard of care; Standard intraoperative opioid regimen (control)
Experimental: Methadone	Drug: Methadone; Methadone 0.2 mg/kg (max 20 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in numeric rating scale (NRS) pain scores	Pain scores recorded in the electronic medical record (EMR) using the NRS scale 0-10. A higher score indicates greater pain level. Will track scores over first 24 hours following surgery completion (as determined by PACU arrival)	PACU arrival to 24 hours postoperative
Time in PACU	Will measure duration of time patient spends in the PACU (measured in hours)	PACU arrival to PACU discharge (determined by time of PACU discharge note entry). Assess up to 24 hours postoperatively.
Hospital Length of Stay	Duration of time the patient spends in the hospital. Measured in days	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	The incidence of respiratory depression would be defined by any of the following: respiratory rate < 10 breaths/min for >5 min; SpO₂ < 90% for >5 min (SpO₂ <88% if history of COPD); PaCO₂ > 50 mmHg AND increased more than 20% of baseline (if baseline known); Naloxone use postoperatively The following events will be documented in the electronic medical record (EMR) and study personnel will chart review for documented incidence of the criteria above and report findings. Will be reported as a "yes" or "no".	Measured from time of PACU admission until 72 hours postoperatively.
Incidence of Postoperative nausea and vomiting	Incidence of postoperative nausea or vomiting will be recorded in the electronic medical record (EMR) and study personnel will chart review for documented incidence of postoperative nausea or vomiting during the first 72 hours postoperatively.	Assessed postoperatively up to 72 hours after documented PACU admission time
Patient Satisfaction	Patient satisfaction survey will be administered by study staff 24 hours postoperatively to measure the patient satisfaction of their postoperative pain management. The survey will measure the following over the 24 postoperatively: the patients pain level on a scale from 1-10, their pain control adequacy from very poorly to very well, functional impact on getting out of bed, walking, deep breathing/coughing, physical therapy, sleeping or none, side effects of opioids including: nausea, vomiting, itching, constipation, excessive sleepiness, dizziness, or confusion, and their satisfaction level of pain management from very dissatisfied to very satisfied.	Postoperative until 24 hours postoperative

Collaborators and Investigators

• Sponsor: Brandon Knopp

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: methadone; opioids; spine surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Health Services Administration; Health Care Quality, Access, and Evaluation; Organic Chemicals; Quality of Health Care; Quality Indicators, Health Care; Ketones; Methadone; Standard of Care
• Other Study ID Numbers: 111197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes