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

RecruitingPhase 3Ages 18 Years - 85 YearsAllIcahn School of Medicine at Mount Sinai
NCT07548385 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Suzetrigine
  • Placebo
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Where

1 site
Mount Sinai West
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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