Actively Recruiting
Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-04-23
235
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 85 years old
- Scheduled to undergo total knee replacement surgery
- All genders
You will not qualify if you...
- American Society of Anesthesiology Physical Classification (ASA) Class V
- Urgent or emergent surgery
- Contraindications to Suzetrigine: taking moderate-to-severe CYP3A inhibitors (e.g., Ritonavir, Voriconazole, Clarithromycin)
- Contraindications to Suzetrigine: taking moderate-to-severe CYP3A inducers (e.g., Phenytoin, Carbamazapine, Rifabutin)
- Moderate to severe hepatic impairment
- History of substance use disorder, chronic opioid use, or alcohol abuse
- Reoperation
- Patient refusal or inability to consent
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mount Sinai West
New York, New York, United States, 10019
Actively Recruiting
Research Team
M
Michael Lazar, MD
CONTACT
H
Himani Bhatt, DO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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