Role of Suzetrigine as a Part of a Multimodal Regimen to Reduce Pain and Opioid Use After Total Knee Arthroplasty
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
The objective of the study is to determine the effect suzetrigine has on postoperative pain, opioid use, sleep quality, and patient satisfaction when it is used as part of a multimodal pain regimen prescribed to patients after total knee arthroplasty.
The study will enroll eligible participants who are scheduled to receive a total knee arthroplasty. Participants will first consent to participate in the research study. They will then be asked to complete certain baseline measurements and instructed to begin wearing a device on their wrist that will quantify their activity and sleep quality ("sleep tracker"). They will complete a baseline KOOS JR survey. There are no additional surveys or diaries to complete pre-operatively. They will receive a suzetrigine prescription (the intervention) on the day of their total knee arthroplasty after the procedure has been completed in addition to the standard of care pain control regimen after surgery. They will complete a diary for a set time after surgery, and subject will continue to wear the sleep tracker for up to 2 weeks post-surgery. They will complete a daily sleep diary for 14 days after surgery to document sleep duration, sleep quality, nighttime awakenings, and other related factors. They will also complete a diary for 14 days after surgery that asks them to report their pain level 3 times daily, their nausea level 3 times daily, and the number of narcotic pills taken daily, and continue to wear their activity and sleep tracker. They will be asked to complete a pill tracking chart to confirm they are taking Journavx as directed for 14 days after surgery. 1 week and 2 weeks after surgery, they will complete a survey that quantifies their sleep related impairment. Approximately 3 months after surgery, subjects will complete another survey. Participants will have interactions with the study team until approximately 3 months after surgery.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 4
Контакты и местонахождение
Контакты исследования
- Имя: Darrell Favors
- Номер телефона: 404-313-3276
- Электронная почта: darrell.favors@emory.edu
Места учебы
-
-
Georgia
-
Atlanta, Georgia, Соединенные Штаты, 30322
- Emory Clinic
-
Atlanta, Georgia, Соединенные Штаты, 30329
- Emory Clinic at Executive Park
-
Atlanta, Georgia, Соединенные Штаты, 30329
- Emory Orthopaedics and Spine Center
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee.
- Patients between the ages of 18 and 95 years.
Exclusion Criteria:
- Patients with concurrent and significant injuries to other bones or organs.
- Patients with local infections.
- Minors unable to provide informed consent for participation in the study.
- Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
- Patients with pre-existing immune suppression, where further immune suppression with GCs could warrant unwarranted or unneeded risk.
- Patients with preoperative opioid use, defined as daily use less than 4 weeks before the index surgery.
- Patients with a history of severe heart disease (NYHA2), renal failure, or liver dysfunction
- Patients with active peptic ulcer disease.
- Patients neurological or psychiatric diseases, potentially influencing pain perception
- Patients who are pregnant.
- Patients with a history of alcohol or medical abuse, allergies to glucocorticoids, current daily use of glucocorticoids.
- Patients who are unable to take NSAIDs.
- Patients who receive Deep Venous Thrombosis (DVT) prophylaxis different than Aspirin (81mg) twice daily (BID).
- Patients who have known diabetes mellitus as defined with an A1C greater than 6.5%.
- Patients currently taking CYP3A inhibitors
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Suzetrigine Regimen Arm
Suzetrigine (JOURNAVX®) administered orally consisting of a course that lasts up to a maximum of 14 days. The starting dose will be 100 mg orally taken as two 50 mg tablets on an empty stomach (at least 1 hour before or 2 hours after food). Maintenance dosing will begin 12 hours after the initial dose, at which point patients will take 50 mg orally every 12 hours. |
Suzetrigine is an orally administered, selective NaV1.8 voltage-gated sodium channel inhibitor being investigated as a non-opioid analgesic for the treatment of pain through inhibition of pain signal transmission in peripheral sensory neurons.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Mean pain intensity score on the Numeric Rating Scale (NRS)
Временное ограничение: Day 0-14 postoperative
|
Pain will be measured using a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, using a Visual Analog Pain Scale (VAS-pain).
Higher score correlates with worse outcome.
|
Day 0-14 postoperative
|
|
Average daily opioid consumption
Временное ограничение: Day 0-14 postoperative
|
Postoperative opioid consumption will be quantified in morphine milligram equivalents (MME) during postoperative days 0-14.
|
Day 0-14 postoperative
|
|
Cumulative opioid consumption
Временное ограничение: 3 weeks and 3 months postoperative
|
Postoperative opioid consumption will be quantified as cumulative MME at 3 weeks and 3 months.
|
3 weeks and 3 months postoperative
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Nausea scores postoperative
Временное ограничение: Day 0-14 post-operative
|
A nausea assessment will be assessed using the Visual Analog Nausea Scale (VAS-nausea), which is ranked from 0 (no nausea) to 10 (highest amount of nausea).
Patients will be asked to fill out the VAS-nausea each day until post-operative day 14.
|
Day 0-14 post-operative
|
|
Total sleep time
Временное ограничение: Day 0-14 post-operative
|
Total sleep time will be collected using actigraphy during postoperative days 0-14.
|
Day 0-14 post-operative
|
|
Sleep efficiency
Временное ограничение: Day 0-14 post-operative
|
Sleep efficiency will be measured by recording the ratio of time asleep to time in bed, using actigraphy during postoperative days 0-14.
|
Day 0-14 post-operative
|
|
Sleep latency
Временное ограничение: Day 0-14 post-operative
|
Sleep latency will be measured by recording the time from "lights out" to sleep onset, using actigraphy during postoperative days 0-14.
|
Day 0-14 post-operative
|
|
Wake after sleep onset (WASO)
Временное ограничение: Day 0-14 post-operative
|
Wake after sleep onset (WASO) will be assessed using actigraphy during postoperative days 0-14.
|
Day 0-14 post-operative
|
|
EQ5D Score
Временное ограничение: 3 months post-operative
|
Health-related quality of life measure using the EQ-5D questionnaire, which assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Responses are converted into a summary index score, where 1 represents full health and 0 represents death (higher values indicating better health status).
|
3 months post-operative
|
|
KOOS Jr Score
Временное ограничение: Baseline, 3 months post-operative
|
Patient-reported knee function assessed using the Knee Injury and Osteoarthritis Outcome Score Junior (KOOS Jr).
The KOOS Jr is a validated short-form instrument derived from the full KOOS, designed to evaluate knee health based on key items related to pain, symptoms, and physical function.
Scores are transformed to a 0 to 100 scale, with higher scores indicating better knee function and fewer symptoms.
|
Baseline, 3 months post-operative
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Ajay Premkumar, MD, Emory University
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2026P000242
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .