Intraoperative methadone for pain control after total hip replacement
Reduction of Post-op Pain and Opioid Consumption With the Addition of Methadone in Total Hip Arthroplasty: a Double-blind Randomized Control Trial
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 |
| 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 | NCT07227064 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Charleston, South Carolina
- 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
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.