NCT07548385PHASE3Recruiting
Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN
Icahn School of Medicine at Mount Sinai
Start Date
4/1/2026
Completion Date
2/23/2027
Summary
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.
Eligibility Criteria
Age Range: 18 years to 85 years
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
Interventions
DRUG
Suzetrigine
DRUG
Placebo
Conditions
Total Knee Replacement SurgeryPost-operative Pain
Locations
Mount Sinai West
New York, New York 10019
United States