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NCT Number: NCT07485803

Methadone in the Management of Post-Operative Pain in Total Knee Replacement

The goal of this study is to determine whether one dose of IV methadone given right before surgery will help patients' pain management after a total knee replacement and reduce the amount of pain medications taken in the weeks after surgery.

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Key information

Conditions

Total Knee Arthroplasty Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AdventHealth Porter

Denver, Colorado, 80210, United States

Location status: Recruiting

Location contact

Makenna Hemmerle

CONTACT

[email protected]

3032602951

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of signed and dated informed consent from
  • Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study.
  • Age 21- 75
  • Unilateral total knee arthroplasty at Colorado Joint Replacement
  • All individuals will be screened for drug use (opioid use, illicit drug use) at their preoperative appointment
  • For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.

Exclusion criteria

  • Narcotic use in the past 6 weeks
  • Current or previous history of drug and alcohol abuse
  • Tobacco use in the previous 90 days
  • Treatment with another investigational drug
  • Patients that cannot receive spinal anesthesia
  • Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)'
  • Patients that are not able to go home after leaving the hospital and require a short-term rehabilitation facility
  • Obstructive sleep apnea
  • Morbid obesity (BMI >40)
  • Patients with liver disease.
  • Significant kidney disease - stage 3 CKD or greater
  • Pregnant or nursing females
  • Baseline QTc >480
  • severe COPD (GOLD 3 or 4)
  • home oxygen requirement

Treatment and study plan

Methadone

Drug

Subjects randomized to receive methadone will be given one dose of methadone 0.15mg/kg intravenously dosed based on ideal body weight administered by the anesthesia team prior to surgical incision

Primary outcomes

  1. Opioid use for 48 hours post-operatively

    Time frame: 48 hours after TKA procedure

    Opioid use will be calculated using morphine milligram equivalents (MME). Patients will keep a log to track opioid consumption.

Secondary outcomes

  1. Defense and Veterans Pain Scale

    Time frame: 2 weeks after TKA procedure

    Using the Defense and Veterans Pain Scale, patients will rate their pain ranging from 0 (no pain) to 10 (severe pain)

  2. Opioid-Related Symptom Distress Scale (ORSDS)

    Time frame: At baseline and 2 weeks after TKA procedure

    4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4.

  3. Pittsburgh Sleep Quality Index

    Time frame: At baseline and 2 weeks after TKA procedure

    Patients will complete survey to monitor sleeping habits

  4. Total opioid usage over 2 weeks post-operatively

    Time frame: 2 weeks after TKA procedure

    Opioid use will be calculated using morphine milligram equivalents (MME). Patients will keep a log to track opioid consumption.

  5. Knee Society Score

    Time frame: At baseline

    This survey includes alignment, instability, joint range of motion, and symptoms. A higher score indicates good alignment, range of motion, and minimal symptoms of pain. A lower score indicates poor knee alignment, potential issues in range of motion, and the likely experience of symptoms of pain.

  6. KOOS-12 Knee Survey

    Time frame: At baseline

    This survey is used to evaluate knee pain, function and quality of life. The total score ranges from 0 to 100, where higher scores indicate better outcomes.

  7. Veterans Rand 12-Item Health Survey (VR-12)

    Time frame: At baseline

    This survey assesses overall health-related quality of life across physical and mental domains. It generates two summary scores-Physical Component Summary (PCS) and Mental Component Summary (MCS)-to provide a standardized evaluation of a patient's functional health and well-being.

Study contacts

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

Makenna Hemmerle

CONTACT

[email protected]

303-260-2951

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study title

A Prospective, Randomized Trial Utilizing Methadone in the Management of Post-Operative Pain in Total Knee Replacement

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 20, 2026
Registry last updated
Jun 22, 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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