Methadone in THA for Post-op Pain and Opioid Reduction

Medical University of South Carolina (MUSC)

Status and phase: Enrolling; Phase 3

Conditions: Total Hip Arthroplasty; Post Operative Pain

Treatments: Drug: Methadone

Study type: Interventional

Funder types: Other

Identifiers

NCT07227064

Pro00147100

Details and patient eligibility

About

This randomized, double-blind controlled trial investigates whether intraoperative intravenous methadone (0.15 mg/kg based on ideal body weight) reduces acute postoperative pain and opioid consumption in patients undergoing elective total hip arthroplasty under spinal anesthesia with mepivacaine. The primary outcome is patient-reported pain on a visual analog scale (VAS) 30-60 minutes after arrival in the post-anesthesia care unit (PACU). Secondary outcomes include opioid use, pain scores over time, incidence of nausea/vomiting, and quality of recovery. A total of 162 subjects will be enrolled at MUSC surgical sites.

Enrollment: 162 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 2 patient groups

Methadone

Active Comparator group

Description:

Patients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight.

Treatment:

Drug: Methadone

No Methadone

No Intervention group

Description:

Patients will NOT receive methadone.