NCT07145346

Suzetrigine for Acute Pain Control in Patients With Multiple Rib Fractures

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

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rib Fractures

Interventions

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

Timeline

• Start date: 2025-11-13
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-08-28
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study