Recruiting
Phase 3

Methadone

Sponsor:

Medical University of South Carolina

Code:

NCT07226076

Conditions

Post Operative Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Methadone Hydrochloride

Study Details

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

Study ID

NCT07226076

Start date

Jan 8, 2026

Status verified date

Feb, 2026

Completion date

Jan 15, 2027

Anticipated

Primary completion date

Dec 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

162 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Methadone Hydrochloride

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

Primary outcome measure

  • Patient reported pain in the recovery unit after surgery [ Time Frame: up to 24 hours after surgery ends ]

Central Contacts and Locations

Central contacts

Haley Nitchie, MHA

843-792-1869nitchie@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Haley Nitchie, MHA

843-792-1869nitchie@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

  • post-operative pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-02-04.