Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange 5379513, California 5332921
Dates
study started
study ends around
Principal Investigator
by Jeffrey Nahmias, MD

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Rib Fractures, blunt chest trauma, Suzetrigine, multimodal pain regimen, Counterfeit Drugs, Suzetrigine (SUZ)

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • < 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

Location

  • University of California, Irvine
    Orange 5379513 California 5332921 92868 United States

Lead Scientist at UC Irvine

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT07145346
Phase
Phase 4 Rib Fracture Research Study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated