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Набира участници Фаза 3 NCT07548385

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Total Knee Replacement Surgery Post-operative Pain

Спонсор: Icahn School of Medicine at Mount Sinai

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Интервенции
Suzetrigine
DRUG
Placebo
DRUG
Места на провеждане 1
САЩ (1)
Mount Sinai West
New York , New York
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
85 Years
Здрави доброволци
Не
Начална дата
01.04.2026
Крайна дата
23.02.2027
Регистрационен номер
NCT07548385
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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