Suzetrigine for Acute Pain Control in Patients With Multiple Rib Fractures

Not Applicable

Not yet recruiting

• Conditions: Rib Fractures
• Interventions: Drug: Suzetrigine (SUZ); Drug: Placebo

• Registration Number: NCT07145346
• Lead Sponsor: University of California, Irvine

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Study First Posted: 2025-08-28
• Last Update Posted: 2025-08-28
• Primary Completion: 2027-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• < 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Evaluation of Pain	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	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.

Secondary Outcome Measures

Name	Time	Method
Epidural Administration	Through study completion of index hospitalization (up to 2 years)	Epidural use - patients that fail pain management will be offered an epidural
Time in the Hospital	Through study completion of index hospitalization (up to 2 years)	ICU length of stay - number of days in the ICU Hospital length of stay - number of days admitted to the acute care hospital
Respiratory Complications	Through study completion of index hospitalization (up to 2 years)	Respiratory complications - include events such as unplanned intubation, pneumonia, pneumothorax and incentive spirometry
Mortality	Through study completion of index hospitalization (up to 2 years)	Mortality - in-hospital mortality rate and 30-day mortality

Trial Locations

Locations (1)

University of California, Irvine; 🇺🇸 Orange, California, United States