Suzetrigine for Acute Pain Control in Patients With Multiple Rib Fractures

Официальное название

Suzetrigine for Acute Pain Control in Patients With Multiple Rib Fractures: A Randomized Controlled Trial

Обзор

Rib fractures cause a significant amount of pain and are associated with an increased risk of lung infections, long hospitalization, and increased cost. Effective pain control is the cornerstone of management to improve lung function and minimize complications. Most often this is done with a multimodal pain routine consisting of: acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), topical lidocaine, muscle relaxants, and opioids. However, suzetrigine is a promising alternative to treat acute pain associated with rib fractures. We think the addition of suzetrigine to a multimodal pain regimen will improve pain and decrease opioid use.

Подробное описание

Rib fractures are a common and painful injury associated with increased risk of pneumonia, prolonged hospitalization, and higher healthcare utilization. In a national database review, rib fractures were associated with a 10% mortality rate, with mortality increasing incrementally with each additional rib fractured. Effective analgesia is essential in management of these injuries, as improved pain control optimizes pulmonary mechanics and reduces complications. Current analgesic strategies include multimodal pain regimens consisting of oral and transdermal analgesics or regional anesthetics such as epidural catheters. Historically, opioids have been a major component of analgesia, however they are highly addictive and can lead to respiratory depression and epidurals are invasive procedures with associated risks.

Suzetrigine (Journavx) is a newly United States Food and Drug Administration (FDA)-approved, oral non-opioid analgesic that selectively inhibits the NaV1.8 voltage-gated sodium channel, which is solely expressed in peripheral nociceptive neurons. A systematic review including multiple phase III trials demonstrated suzetrigine's efficacy for pain management in both non-surgical and post-surgical patients. Suzetrigine has also been shown to have comparable analgesia to oral opioids with fewer side effects, such as nausea, vomiting, and need for rescue pain medication.

Вмешательства

• Препарат Suzetrigine (SUZ)
  The intervention arm will receive oral suzetrigine (100 mg loading dose followed by 50 mg every 12 hours).
• Препарат Placebo
  The control arm will receive placebo capsules matched to suzetrigine for oral administration.

Первичные конечные точки

• Evaluation of Pain [Срок оценки: Through study completion of index hospitalization (up to 2 years)]
• Use of morphine and morphine equivalents [Срок оценки: Through study completion of index hospitalization (up to 2 years)]

Вторичные конечные точки (4)

• Epidural Administration [Срок оценки: Through study completion of index hospitalization (up to 2 years)]
• Time in the Hospital [Срок оценки: Through study completion of index hospitalization (up to 2 years)]
• Respiratory Complications [Срок оценки: Through study completion of index hospitalization (up to 2 years)]
• Mortality [Срок оценки: Through study completion of index hospitalization (up to 2 years)]

Критерии участия

Критерии включения

• > 18 years old
• Blunt trauma patients
• > 3 rib fractures
• Able to tolerate oral intake

Критерии исключения

• < 17 years old
• Pregnant
• Prisoners
• History of adverse reaction to suzetrigine
• Current strong CYP3A inhibitor medication use

o Strong Inhibitors: clarithromycin, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, atazanavir, darunavir, indinavir, lopinavir, telithromycin

• Current strong or moderate CYP3A inducer

• Strong Inducers: apalutamide, carbamazepine, encorafenib, enzalutamide, fosphenytoin, lumacaftor and ivacaftor, mitotane, phenytoin, rifampin
• Moderate Inducers: bexarotene (Systemic), bosentan, cenobamate, dabrafenib, dipyrone, efavirenz, elagolix, estradiol, and norethindrone, eslicarbazepine, etravirine, fexinidazole, lorlatinib, mitapivat, modafinil, nafcillin, pacritinib, pexidartinib, phenobarbital, primidone, repotrectinib, rifabutin, rifapentine, sotorasib, St John's Wort
• Cirrhosis
• GCS < 14
• Rhabdomyolysis (CPK > 5,000 U/L)
• Chronic opioid use (>30mg OME/day)
• Known or suspected active infection with human immunodeficiency virus or hepatitis B or C viruses

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of California, Irvine — Orange

Публикации

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Идентификаторы

NCT: NCT07145346 · 7663

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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