Intraoperative methadone for pain control after total hip replacement
Official title: Reduction of Post-op Pain and Opioid Consumption With the Addition of Methadone in Total Hip Arthroplasty: a Double-blind Randomized Control Trial
Run by Medical University of South Carolina · NCT07227064 · Data updated 2026-11-12
This trial tests whether a single intraoperative IV dose of methadone lowers immediate postoperative pain and reduces opioid use in adults having elective total hip replacement with spinal anesthesia.
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 12, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | January 31, 2027 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT07227064 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 years old undergoing elective primary total hip arthroplasty with spinal anesthesia using mepivacaine who can provide informed consent, are not pregnant, and do not have exclusions such as methadone or mepivacaine allergy, severe liver disease, end-stage renal disease on dialysis, or prolonged QT syndrome are ideal candidates.
✕Probably not a fit
Patients who do not meet inclusion criteria or who have exclusion conditions (for example pregnancy, severe liver disease, dialysis-dependent renal failure, prolonged QT, or allergies) or who undergo general anesthesia instead of the specified spinal technique are unlikely to benefit from this protocol.
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 where participants receive a single dose of IV methadone (0.15 mg/kg ideal body weight) during elective primary total hip arthroplasty performed under spinal anesthesia with mepivacaine. The primary outcome is patient-reported pain on a visual analog scale 30–60 minutes after arrival in the post-anesthesia care unit. Secondary outcomes include opioid consumption, pain scores over time, incidence of nausea and vomiting, and quality of recovery. The study will enroll 162 subjects at Medical University of South Carolina surgical sites and compare postoperative outcomes between methadone and control groups.
Why it matters
Potential benefit: If successful, a single intraoperative methadone dose could reduce early postoperative pain and opioid requirements, possibly lowering opioid-related side effects and improving recovery.
How similar studies have gone: Prior randomized studies in various surgical populations, including some orthopedic procedures, have shown that intraoperative methadone can reduce postoperative opioid use and pain, though results have varied and further confirmation is needed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion * Ages 18-75 years of age * Undergoing elective primary total hip 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: Christopher Fatora, MD — 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.