Methadone in TKA for Post-op Pain and Opioid Reduction
Recruiting
Phase 3
Interventional Study
Post Operative Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 162 (estimated)
- Sponsor
- Medical University of South Carolina · Other
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About This Trial
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.
Trial Locations
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Eligibility 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…
Contacts