Methadone in THA for Post-op Pain and Opioid Reduction

Purpose

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.

Conditions

  • Post Operative Pain
  • Total Hip Arthroplasty

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Methadone
Patients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight.
  • Drug: Methadone
    Patients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight.
No Intervention
No Methadone
Patients will NOT receive methadone.

Recruiting Locations

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
Contact:
Haley Nitchie, MHA
843-792-1869
nitchie@musc.edu

More Details

Status
Recruiting
Sponsor
Medical University of South Carolina

Study Contact

Haley Nitchie, MHA
843-792-1869
nitchie@musc.edu