Can ACL surgery recovery skip the opioids?

NCT ID NCT06561035

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are comparing two pain-control plans for people having anterior cruciate ligament (ACL) reconstruction surgery. One plan uses a mix of non-opioid medicines to spare or reduce opioid painkillers, while the other follows a standard opioid-based approach. The trial measures pain scores and how many opioid pills participants take after surgery. It also tracks side effects. The study enrolls people aged 14 to 85 who are having primary ACL reconstruction, with or without related knee procedures.

What this could mean

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

Active substance
a pain-control plan that uses non-opioid medicines alongside or instead of opioid painkillers
What this could lead to
If the opioid-sparing plan controls pain as well as standard opioid painkillers, it could give patients having ACL surgery a way to recover with fewer or no opioid pills.
What could go wrong
The trial is small, with 56 planned participants, and results may not apply to people with more complex knee injuries or other surgeries. Some patients may still need opioids for adequate pain relief.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 56 people

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

Started

Sep 2024

Expected to finish

Mar 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

14 to 85 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: * 14-85 years of age. * Patients undergoing primary ACL-R with or without meniscus repair or meniscectomy, with or without chondroplasty. * Patients weigh at least 90lbs at time of enrollment. * Surgery scheduled at a Campbell Clinic Surgery Center (Midtown or Wolf River). * Willing and able to provide written informed consent. * Willing and able to cooperate with postoperative therapy. * Speak and read fluent English. Exclusion Criteria: * Multiligament knee reconstruction. * Pre-injury opioid consumption. * Substance abuse disorder (illicit drug abuse, alcoholism, etc). * Concomitant injuries or surgeries warranting pain medication (i.e. polytrauma patient). * Chronic pain syndrome. * Renal disease. * Currently taking selective serotonin reuptake inhibitors and/or serotonin and norepinephrine reuptake inhibitors. * Known sensitivity, allergy, or intolerance to medications within protocols. * History of diabetes. * Currently taking glucagon-like peptide 1 agonist. * Female patient who is pregnant on day of surgery or becomes pregnant during study period.

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Conditions

The condition(s) this trial relates to.

Anterior Cruciate Ligament Injuries

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  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

  • Campbell Clinic

    Memphis, Tennessee, 38138, United States

  • Endeavor Health

    Skokie, Illinois, 60076, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

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