Not Yet RecruitingPhase 4

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

192 participantsStarted 2026-06

Plain-language summary

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.

Who can participate

Age range21 Years – 75 Years

SexALL

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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

What they're measuring

Opioid use for 48 hours post-operatively

Timeframe: 48 hours after TKA procedure

Trial details

NCT IDNCT07485803

SponsorAdventHealth

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04

Contact for this trial

Makenna Hemmerle

303-260-2951 makenna.hemmerle@adventhealth.com

View on ClinicalTrials.gov More Total Knee Arthroplasty trials