Suzetrigine to reduce pain after total knee replacement

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

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

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 235 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT07548385 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

New York, New York

• Mount Sinai West — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Michael Lazar, MD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Michael Lazar, MD

Conditions Total Knee Replacement Surgery; Post-operative Pain