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

ID#: NCT07548385

Age: 18 - 85 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: April 01, 2026

End Date: February 23, 2027

Contact Information:
Michael Lazar, MD
212-523-2500
Himani Bhatt, DO
212-523-2500
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:

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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