Methadone in TKA for Post-op Pain and Opioid Reduction

NCT07226076 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: Pro00147447
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain

Keywords

post-operative pain

Outcome Measures

Primary Outcomes (1)

• Patient reported pain in the recovery unit after surgery

  Patient reported pain on a Visual Analog Scale (VAS) from 0-100mm at approximately 30-60 minutes after arriving to the recovery unit after surgery. A lower pain score means a better outcome.

  up to 24 hours after surgery ends

Secondary Outcomes (5)

• Opioid Consumption in the recovery unit

  PACU Arrival until PACU Discharge up to 30 days

• Time to first opioid rescue dose

  up to 24 hours after surgery ends

• Pain scores

  PACU, 24 hours, 48 hours, and 72 hours post-operatively.

• Postoperative nausea and/or vomiting

  PACU through 72 hours post-operatively

• Quality of Recovery

  up to 24-hours post-operatively

Study Arms (2)

Methadone

ACTIVE COMPARATOR

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

Drug: Methadone Hydrochloride

No Methadone

NO INTERVENTION

Patients will NOT receive methadone.

Interventions

Methadone Hydrochloride DRUG

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

Methadone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-75 years of age
• Undergoing elective primary total knee arthroplasty with mepivacaine in the spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methadone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• William Barrett, M.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haley Nitchie, MHA

CONTACT

843-792-1869; nitchie@musc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Faculty

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 10, 2025
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)