Methadone in TKA for Post-op Pain and Opioid Reduction

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified January 2026 by Medical University of South Carolina
Sponsor
Medical University of South Carolina
Information Provided by (Responsible Party)
William Barrett
Clinicaltrials.gov Identifier
NCT07226076
Other Study ID Numbers:
Pro00147447
First Submitted
November 5, 2025
First Posted
November 9, 2025
Last Update Posted
February 3, 2026
Last Verified
January 2026

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

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Post Operative Pain
Drug: Methadone Hydrochloride

Study Design

Study TypeInterventional
Actual Enrollment162 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleReduction of Post-op Pain and Opioid Consumption With the Addition of Methadone in Total Knee Arthroplasty: a Double-blind Randomized Control Trial
Study Start DateJanuary 7, 2026
Actual Primary Completion Date6mos 3w from now
Actual Study Completion Date7mos 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Methadone
Patients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight.
Drug: Methadone Hydrochloride
Patients will intraoperatively be administered methadone 0.15mg/kg IV, based on ideal body weight.
No Methadone
Patients will NOT receive methadone.

Outcome Measures

Primary Outcome Measures
  1. Patient reported pain in the recovery unit after surgery
    Patient reported pain on a Visual Analog Scale (VAS) from 0-100mm at approximately 30-60 minutes after arriving to the recovery unit after surgery. A lower pain score means a better outcome.
Secondary Outcome Measures
  1. Opioid Consumption in the recovery unit
    Opioid consumption measured in oral morphine milligram equivalents (MMEs) while the patient is in the PACU (Post-Anesthesia Recovery Unit).
  2. Time to first opioid rescue dose
    Measured from the PACU arrival time, to the time the first opioid rescue dose is given while in the PACU.
  3. Pain scores
    Visual Analog Score (VAS) 0-100mm reporting pain at rest, and with movement. A lower pain score means a better outcome.
  4. Postoperative nausea and/or vomiting
    Incidence of postoperative nausea and/or vomiting after surgery as reported by the patient.
  5. Quality of Recovery
    Change in quality of recovery score from baseline to 24-hours post-operatively measured using the Quality of Recovery 15 Assessment (QoR-15). This assessment is scored 0-150, with a higher score indicating a better quality of recovery. Each of the 15 questions is on an 11-point numerical rating scale from 0-10, and the selections are added together to result in the total score.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Inclusion
Ages 18-75 years of age
Undergoing elective primary total knee arthroplasty with mepivacaine in the spinal anesthesia
Exclusion Criteria
Inclusion
Ages 18-75 years of age
Undergoing elective primary total knee arthroplasty with mepivacaine in the spinal anesthesia Exclusion
Allergy to methadone or mepivacaine
Severe liver disease defined as Child's Pugh Class C
End stage renal disease requiring dialysis
Known diagnosis of prolonged QT syndrome
Currently pregnant
Unable to provide written, informed consent
Non-English speaking

Contacts and Locations

Sponsors and CollaboratorsMedical University of South Carolina
Locations
Medical University of South Carolina | Charleston South Carolina, United States, 29425
Investigators
Principal Investigator: William Barrett, M.D., Medical University of South Carolina