Methadone for Post-operative Spine Surgery

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified May 2026 by Brandon Knopp
Sponsor
Brandon Knopp
Information Provided by (Responsible Party)
Brandon Knopp
Clinicaltrials.gov Identifier
NCT07517679
Other Study ID Numbers:
111197
First Submitted
March 23, 2026
First Posted
April 7, 2026
Last Update Posted
July 19, 2026
Last Verified
May 2026

ClinicalTrials.gov processed this data on July 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Pain, Postoperative
Drug: MethadoneDrug: Standard of care

Study Design

Study TypeInterventional
Actual Enrollment30 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleEffect of Post-Induction Methadone on Postoperative Pain, Opioid Use, and Recovery in Spine Surgery
Study Start DateJune 9, 2026
Actual Primary Completion Date7mos 3w from now
Actual Study Completion Date7mos 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Methadone
Drug: Methadone
Methadone 0.2 mg/kg (max 20 mg)
Standard of care
Drug: Standard of care
Standard intraoperative opioid regimen (control)

Outcome Measures

Primary Outcome Measures
  1. Perioperative Opioid use in morphine equivalents (ME)
    perioperative opioid use (morphine equivalents (ME): intraoperative, PACU, and 72-hour totals)
Secondary Outcome Measures
  1. 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)
  2. Time in PACU
    Will measure duration of time patient spends in the PACU (measured in hours)
  3. Hospital Length of Stay
    Duration of time the patient spends in the hospital. Measured in days
  4. 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".
  5. 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.
  6. 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsBrandon Knopp
Locations
University of Kentucky | Lexington Kentucky, United States, 40536