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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Total Knee Replacement Surgery, Post-operative Pain

In brief

This is a prospective, randomized study. The purpose of this study is to evaluate if the addition of Suzetrigine, a new pain medication, to well established peri-operative pain regimen used for total knee replacement surgery will effect pain control. 1. Does Suzetrigine given pre-operatively decrease the total opioid consumed after total knee replacement surgery? 2. Dose Suzetrigine given pre-operatively decrease the visual analog pain scale pain scores after total knee replacement surgery? Study participants will be randomly assigned to receive either Suzetrigine medication or placebo medication.

Key facts

Study ID

NCT07548385

Run by

Icahn School of Medicine at Mount Sinai

People needed

235

Starts

2026-04-01

Expected to finish

2027-02-23

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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