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One dose before surgery: could methadone ease knee replacement pain?

NCT ID NCT07485803

Symptom relief Sponsor: AdventHealth Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether giving one dose of methadone just before total knee replacement surgery can help control pain afterward and reduce the amount of other painkillers needed. About 192 adults aged 21-75 having a knee replacement will be randomly assigned to receive methadone or not. Researchers will track opioid use for 48 hours after surgery and measure pain levels using standard scales.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methadone
What this could lead to
If it works, this could offer a simple, single-dose way to better manage pain after knee replacement and reduce the need for other opioids.
What could go wrong
This is a small, early-phase study (Phase 4) with 192 participants, so results may not apply to everyone. Methadone itself is an opioid and carries risks like respiratory depression or addiction.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 192 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provision of signed and dated informed consent from 2. Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study. 3. Age 21- 75 4. Unilateral total knee arthroplasty at Colorado Joint Replacement 5. All individuals will be screened for drug use (opioid use, illicit drug use) at their preoperative appointment 6. 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: 1. Narcotic use in the past 6 weeks 2. Current or previous history of drug and alcohol abuse 3. Tobacco use in the previous 90 days 4. Treatment with another investigational drug 5. Patients that cannot receive spinal anesthesia 6. Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)' 7. Patients that are not able to go home after leaving the hospital and require a short-term rehabilitation facility 8. Obstructive sleep apnea 9. Morbid obesity (BMI \>40) 10. Patients with liver disease. 11. Significant kidney disease - stage 3 CKD or greater 12. Pregnant or nursing females 13. Baseline QTc \>480 14. severe COPD (GOLD 3 or 4) 15. home oxygen requirement

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Conditions

The condition(s) this trial relates to.

agnosia osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Total knee arthroplasty

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth Porter

    RECRUITING

    Denver, Colorado, 80210, United States

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