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New drug aims to cut opioid use after knee surgery

NCT ID NCT07548385

Symptom relief Sponsor: Icahn School of Medicine at Mount Sinai 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether Suzetrigine, a new pain medication, can improve pain control and reduce opioid use after total knee replacement. About 235 adults scheduled for knee surgery will be randomly assigned to receive either Suzetrigine or a placebo, in addition to standard pain care. The study measures how much opioid painkiller participants need and their pain scores on a 0-10 scale.

What this could mean

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

Active substance
Suzetrigine (a new pain medication that blocks pain signals from nerves)
What this could lead to
If it works, this could provide a new option for managing pain after knee replacement, potentially reducing the need for opioids.
What could go wrong
This is a Phase 3 trial, but results may not show a significant benefit over existing treatments. The drug is still investigational and may have unknown side effects.

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 235 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

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

18 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: To be eligible to participate in this study, an individual must meet all of the following criteria: * Adults 18-85 years old * Scheduled to undergo total knee replacement surgery * All genders Exclusion Criteria: Any individual who meets any of the following criteria will be excluded from participation in this study: * American Society of Anesthesiology Physical Classification (ASA) Class V * Urgent or emergent surgery * Contraindications to administration of Suzetrigine: * Patients who take moderate-to-severe CYP3A inhibitors (such as Ritonavir, Voriconazole, and Clarithromycin) * Patients who take moderate-to-severe CYP3A inducers (such as Phenytoin, Carbamazapine, and Rifabutin) * Patients with moderate to severe hepatic impairment * History of substance use disorder or chronic opioid use or alcohol abuse * Reoperation * Patient refusal or inability to consent * Pregnancy

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative

As listed by the trial registrant

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

Post operative pain Total knee replacement surgery

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

  • Mount Sinai West

    RECRUITING

    New York, New York, 10019, United States

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