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NCT Number: NCT07517679

Methadone for Post-operative 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.

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Key information

Conditions

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

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location status: Recruiting

Location contact

Brandon Knopp, MD

CONTACT

[email protected]

859-218-0097

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methadone

Drug

Methadone 0.2 mg/kg (max 20 mg)

Standard of care

Drug

Standard intraoperative opioid regimen (control)

Primary outcomes

  1. Perioperative Opioid use in morphine equivalents (ME)

    Time frame: Perioperative until 72 hours postoperative

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

Secondary outcomes

  1. Change in numeric rating scale (NRS) pain scores

    Time frame: PACU arrival to 24 hours postoperative

    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)

  2. Time in PACU

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

    Will measure duration of time patient spends in the PACU (measured in hours)

  3. Hospital Length of Stay

    Time frame: 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

    Duration of time the patient spends in the hospital. Measured in days

  4. Incidence of respiratory depression

    Time frame: Measured from time of PACU admission until 72 hours postoperatively.

    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".

  5. Incidence of Postoperative nausea and vomiting

    Time frame: Assessed postoperatively up to 72 hours after documented PACU admission time

    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.

  6. Patient Satisfaction

    Time frame: Postoperative until 24 hours postoperative

    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.

Sponsors and collaborators

Lead sponsor

Brandon Knopp

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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