Comparison of Suzetrigine and Oxycodone for Postoperative Pain After Primary Total Knee Arthroplasty
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: oral suzetrigine, oral Oxycodone.
- Кому может быть актуально
- Состояния в реестре: Osteoarthritis (OA) of the Knee. Базовые параметры: 21 лет — 89 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Comparison of Suzetrigine and Oxycodone for Postoperative Pain and Analgesic Requirements After Primary Total Knee Arthroplasty: a Prospective, Randomized Study
Обзор
The purpose this study is determine whether postoperative oral dosage of suzetrigine is effective at controlling postoperative pain and reducing analgesic requirements following primary total knee arthroplasty (TKA) versus a control group of TKA patients receiving postoperative Oxycodone.
Подробное описание
The purpose of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary total knee arthroplasty (TKA) and to determine whether postoperative administration of oral dosage of suzetrigine is effective at reducing postoperative pain versus a control group of patients receiving oral dosage of oxycodone only following primary total knee arthroplasty.
The primary objective will be to compare the amount of postoperative narcotics utilized and postoperative VAS pain levels. The secondary objective will be to compare variables of patient functionality and other patient-reported outcome measures.
The main questions it aims to answer are:
1. What is the efficacy of oral suzetrigine in reducing opioid consumption and postoperative pain following primary total knee arthroplasty? 2. Will the study results demonstrate the effectiveness and safety of oral suzetrigine after primary total knee arthroplasty in reducing postoperative opioid usage while maintaining a similar or better level of pain control when compared to a standard pain control regimen? Researchers will compare suzetrigine to a standard postoperative pain control regimen (Oxycodone) to see if suzetrigine is equivalent or more effective at reducing opioid consumption and postoperative pain following primary total knee arthroplasty.
Participants will:
* be randomized into one of two groups * undergo a primary TKA * complete a tracking sheet documenting daily pain medicine usage and VAS pain level for the first 14 days following the TKA * return to office at 2 weeks and 6 weeks postop for follow-up * complete additional questionnaires at 2 weeks and 6 weeks postop
Вмешательства
- Препарат oral suzetrigine
patient receives a two-week supply of oral suzetrigine upon discharge - Препарат oral Oxycodone
Patient will receive a two-week supply of oral Oxycodone upon discharge
Первичные конечные точки
- Daily Opioid Use POD 1-14 [Срок оценки: 2 weeks]
- total opioid usage over two weeks [Срок оценки: 2 weeks]
- Use of supplemental opioid POD 1-14 [Срок оценки: 2 weeks]
- VAS pain score over two weeks [Срок оценки: 2 weeks]
- Opioid Usage at 6 weeks postop [Срок оценки: 6 weeks]
Вторичные конечные точки (3)
- VAS Pain Score at 6 weeks [Срок оценки: 6 weeks]
- KOOS, JR. [Срок оценки: preoperatively and 6 weeks (± 2 weeks) postoperatively]
- ROM [Срок оценки: preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively]
Критерии участия
Критерии включения
- Patient age is 21-89 at time of surgery
- Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis
- Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
- Patient is able to read and speak English.
Критерии исключения
- Patient is under the age of 21
- Patient's primary diagnosis is not osteoarthritis
- Patient is unable to read and speak English
- Contraindication or Hypersensitivity to suzetrigine
- Pregnant or nursing females
- Patient has taken opioids within the 90 days prior to enrollment
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Фундаментальное исследование
Центры проведения
США · 1 центр
- UofL Health — Louisville
Публикации
- Mach M, Giba A, Miedziaszczyk M, Bryla A, Szkutnik-Fiedler D. Suzetrigine as a Novel Non-opioid Analgesic Drug in Pain Management: A Review of Clinical Evidence and Therapeutic Perspectives. Cureus. 2025 Aug 22;17(8):e90755. doi: 10.7759/cureus.90755. eCollection 2025 Aug. PMID 40862032
- The Lancet Regional Health-Americas. Opioid crisis: addiction, overprescription, and insufficient primary prevention. Lancet Reg Health Am. 2023 Jul 12;23:100557. doi: 10.1016/j.lana.2023.100557. eCollection 2023 Jul. No abstract available. PMID 37497399
- Robert M, Jouanjus E, Khouri C, Fouilhe Sam-Lai N, Revol B. The opioid epidemic: A worldwide exploratory study using the WHO pharmacovigilance database. Addiction. 2023 Apr;118(4):771-775. doi: 10.1111/add.16081. Epub 2022 Nov 22. PMID 36331523
Идентификаторы
NCT: NCT07219888 · 25.0688