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Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 85

Suzetrigine to reduce pain after total knee replacement

Official title: Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN

Run by Icahn School of Medicine at Mount Sinai · NCT07548385 · Data updated 2026-11-12

This trial tests whether giving Suzetrigine before surgery helps adults having total knee replacement use fewer opioids and have less postoperative pain.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 85 Years
SexAll
Enrollment235 (estimated)
SponsorIcahn School of Medicine at Mount Sinai
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedApril 2026
Main results expectedFebruary 23, 2027
Study endsFebruary 23, 2027
Registry record updatedApril 23, 2026
Trial IDNCT07548385 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–85 of any gender who are scheduled for elective total knee replacement and who are not taking contraindicated CYP3A modulators and do not have significant liver impairment are ideal candidates.

Probably not a fit

Patients with moderate-to-severe hepatic impairment, those taking strong CYP3A inhibitors or inducers, chronic opioid users or those with substance use disorder, emergent or repeat knee surgeries, and pregnant patients are unlikely to be eligible or to benefit from this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, placebo-controlled Phase 3 trial enrolling adults scheduled for total knee replacement at Mount Sinai West. Participants are randomly assigned to receive a preoperative dose of Suzetrigine or a matching placebo in addition to standard perioperative pain care. The main outcomes are total opioid consumption after surgery and pain intensity measured by the visual analog scale. The study excludes patients with significant hepatic impairment, those taking strong CYP3A modulators, chronic opioid users, substance use disorders, emergent surgeries, reoperations, and pregnant patients.

Why it matters

Potential benefit: If effective, Suzetrigine could reduce postoperative pain and the need for opioids after knee replacement, potentially speeding recovery and lowering opioid-related side effects.

How similar studies have gone: Preoperative non-opioid analgesics have reduced opioid use in some prior trials, but Suzetrigine itself is a novel agent and has not been widely tested in large Phase 3 settings.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • Mount Sinai West
    New York, New York, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Total Knee Replacement Surgery 4Post Operative Pain 71Icahn School of Medicine at Mount Sinai 1690
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.