Single-dose IV methadone during knee replacement to lower pain and opioid use
Official title: Reduction of Post-op Pain and Opioid Consumption With the Addition of Methadone in Total Knee Arthroplasty: a Double-blind Randomized Control Trial
Run by Medical University of South Carolina · NCT07226076 · Data updated 2026-11-12
This trial will test whether one intraoperative IV dose of methadone reduces pain and the need for opioid pain pills after elective total knee replacement in adults.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 162 (estimated) |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Status | Recruiting |
| Started | January 8, 2026 |
| Main results expected | December 28, 2026 |
| Study ends | January 15, 2027 |
| Registry record updated | February 4, 2026 |
| Trial ID | NCT07226076 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 75 scheduled for elective primary total knee arthroplasty under spinal anesthesia with mepivacaine who can provide written informed consent and speak English are ideal candidates.
✕Probably not a fit
Patients with methadone or mepivacaine allergy, severe liver disease (Child-Pugh C), end-stage renal disease on dialysis, known prolonged QT syndrome, pregnant individuals, or those receiving nonspinal anesthesia are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled Phase 3 trial enrolling adults having elective primary total knee arthroplasty under spinal anesthesia with mepivacaine. Participants receive a single intraoperative IV dose of methadone (0.15 mg/kg based on ideal body weight) or placebo, with standard perioperative care otherwise. The study measures acute postoperative pain levels and total opioid consumption after surgery. The trial is conducted at the Medical University of South Carolina and is limited to English-speaking participants able to provide written consent.
Why it matters
Potential benefit: If successful, a single intraoperative methadone dose could reduce acute postoperative pain and lower the amount of opioid medication patients need after knee replacement.
How similar studies have gone: Prior randomized and observational studies in various surgical populations, including some joint replacement reports, have suggested intraoperative methadone can reduce postoperative pain and opioid use, but large confirmatory Phase 3 data are limited.
Who can join: the full rules
Show full inclusion / 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
Where it's running
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Medical University of South Carolina
Charleston, South Carolina, United States Recruiting
Study contacts
- Principal investigator: William Barrett, M.D. — Medical University of South Carolina
- Study coordinator: Haley Nitchie, MHA
- Email: nitchie@musc.edu
- Phone: 843-792-1869
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.