Methadone in TKA for Post-op Pain and Opioid Reduction
Purpose
This randomized, double-blind controlled trial investigates whether intraoperative IV methadone (0.15 mg/kg based on ideal body weight) reduces acute postoperative pain and opioid consumption in patients undergoing elective total knee arthroplasty under spinal anesthesia with mepivacaine.
Condition
- Post Operative Pain
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 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator 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
Charleston 4574324, South Carolina 4597040 29425
More Details
- NCT ID
- NCT07226076
- Status
- Recruiting
- Sponsor
- Medical University of South Carolina