Single-dose IV methadone during knee replacement to lower pain and opioid use
Reduction of Post-op Pain and Opioid Consumption With the Addition of Methadone in Total Knee Arthroplasty: a Double-blind Randomized Control Trial
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 |
| Enrollment | 162 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT07226076 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Charleston, South Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.