Suzetrigine for Acute Pain Control in Patients With Multiple Rib Fractures: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluation of Pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Patients will be randomized independently by a third party not involved in patient care or data extraction. Researchers and care providers will be blinded to which arm they are in for the duration of the trail.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years old
- •Blunt trauma patients
- •> 3 rib fractures
- •Able to tolerate oral intake
排除标准
- •< 17 years old
- •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
研究组 & 干预措施
Suzetrigine arm
The intervention arm will receive oral suzetrigine (100 mg loading dose followed by 50 mg every 12 hours).
干预措施: Suzetrigine (SUZ) (Drug)
Control arm
The control arm will receive placebo capsules matched to suzetrigine for oral administration.
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of Pain
时间窗: Through study completion of index hospitalization (up to 2 years)
Pain will be measured on a numerical pain scale from 0 (no pain) to 10 (most pain). Higher pain scores equate to worse outcomes.
Use of morphine and morphine equivalents
时间窗: Through study completion of index hospitalization (up to 2 years)
Oral morphine equivalents (OME) - A study team member will do a chart review and collect morphine used by the patients.
次要结局
- Epidural Administration(Through study completion of index hospitalization (up to 2 years))
- Time in the Hospital(Through study completion of index hospitalization (up to 2 years))
- Respiratory Complications(Through study completion of index hospitalization (up to 2 years))
- Mortality(Through study completion of index hospitalization (up to 2 years))
研究者
Jeffry Nahmias, MD
Chief, Division of Trauma, Burns and Surgical Critical Care
University of California, Irvine