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NCT Number: NCT07226076

Methadone in TKA for Post-op Pain and Opioid Reduction

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Haley Nitchie, MHA

CONTACT

[email protected]

843-792-1869

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methadone Hydrochloride

Drug

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

Primary outcomes

  1. Patient reported pain in the recovery unit after surgery

    Time frame: up to 24 hours after surgery ends

    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.

Secondary outcomes

  1. Opioid Consumption in the recovery unit

    Time frame: PACU Arrival until PACU Discharge up to 30 days

    Opioid consumption measured in oral morphine milligram equivalents (MMEs) while the patient is in the PACU (Post-Anesthesia Recovery Unit).

  2. Time to first opioid rescue dose

    Time frame: up to 24 hours after surgery ends

    Measured from the PACU arrival time, to the time the first opioid rescue dose is given while in the PACU.

  3. Pain scores

    Time frame: PACU, 24 hours, 48 hours, and 72 hours post-operatively.

    Visual Analog Score (VAS) 0-100mm reporting pain at rest, and with movement. A lower pain score means a better outcome.

  4. Postoperative nausea and/or vomiting

    Time frame: PACU through 72 hours post-operatively

    Incidence of postoperative nausea and/or vomiting after surgery as reported by the patient.

  5. Quality of Recovery

    Time frame: up to 24-hours post-operatively

    Change in quality of recovery score from baseline to 24-hours post-operatively measured using the Quality of Recovery 15 Assessment (QoR-15). This assessment is scored 0-150, with a higher score indicating a better quality of recovery. Each of the 15 questions is on an 11-point numerical rating scale from 0-10, and the selections are added together to result in the total score.

Study contacts

Contact information is provided by the study sponsor or research team.

Haley Nitchie, MHA

CONTACT

[email protected]

843-792-1869

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Reduction of Post-op Pain and Opioid Consumption With the Addition of Methadone in Total Knee Arthroplasty: a Double-blind Randomized Control Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Nov 10, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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