RecruitingPhase 4

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

United States192 participantsStarted 2026-06-01

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 range

21 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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