Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN
Icahn School of Medicine at Mount Sinai
235 participants
Apr 1, 2026
INTERVENTIONAL
Conditions
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 Criteria4
- 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 Criteria11
- 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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Interventions
Suzetrigine is a new pain medication that works by inhibiting sodium channels (NAV 1.8) on pain nerves in the peripheral nervous system. By inhibiting this sodium channel on peripheral nerves it blocks pain signals from reaching the spinal cord and brain, decreasing pain.
Matching placebo
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07548385