Methadone in TKA for Post-op Pain and Opioid Reduction

Medical University of South Carolina (MUSC)

Status and phase: Enrolling; Phase 3

Conditions: Post Operative Pain

Treatments: Drug: Methadone Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT07226076

Pro00147447

Details and patient eligibility

About

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.

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 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

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 Hydrochloride

No Methadone

No Intervention group

Description:

Patients will NOT receive methadone.