Suzetrigine for Acute Pain Control in Patients With Multiple Rib Fractures

NCT07145346 | Enrolling By Invitation Phase 4 DMC FDA Drug

• 1 other identifier: 7663
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Rib Fractures

Keywords

blunt chest trauma; rib fractures; Suzetrigine; multimodal pain regimen

Outcome Measures

Primary Outcomes (2)

• Evaluation of Pain

  Pain will be measured on a numerical pain scale from 0 (no pain) to 10 (most pain). Higher pain scores equate to worse outcomes.

  Through study completion of index hospitalization (up to 2 years)

• Use of morphine and morphine equivalents

  Oral morphine equivalents (OME) - A study team member will do a chart review and collect morphine used by the patients.

  Through study completion of index hospitalization (up to 2 years)

Secondary Outcomes (4)

• 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)

Study Arms (2)

Suzetrigine arm

EXPERIMENTAL

The intervention arm will receive oral suzetrigine (100 mg loading dose followed by 50 mg every 12 hours).

Drug: Suzetrigine (SUZ)

Control arm

PLACEBO COMPARATOR

The control arm will receive placebo capsules matched to suzetrigine for oral administration.

Drug: Placebo

Interventions

Suzetrigine (SUZ) DRUG

The intervention arm will receive oral suzetrigine (100 mg loading dose followed by 50 mg every 12 hours).

Suzetrigine arm

Placebo DRUG

The control arm will receive placebo capsules matched to suzetrigine for oral administration.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Orange, California, 92868, United States

Location

Related Publications (9)

• Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209.

  PMID: 27533913 BACKGROUND

• Stawicki SP, Grossman MD, Hoey BA, Miller DL, Reed JF 3rd. Rib fractures in the elderly: a marker of injury severity. J Am Geriatr Soc. 2004 May;52(5):805-8. doi: 10.1111/j.1532-5415.2004.52223.x.

  PMID: 15086666 BACKGROUND

• Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7. doi: 10.1097/00005373-200006000-00007.

  PMID: 10866248 BACKGROUND

• Carver TW, Kugler NW, Juul J, Peppard WJ, Drescher KM, Somberg LB, Szabo A, Yin Z, Paul JS. Ketamine infusion for pain control in adult patients with multiple rib fractures: Results of a randomized control trial. J Trauma Acute Care Surg. 2019 Feb;86(2):181-188. doi: 10.1097/TA.0000000000002103.

  PMID: 30376537 BACKGROUND

• Schnabel A, Meyer-Friessem CH, Reichl SU, Zahn PK, Pogatzki-Zahn EM. Is intraoperative dexmedetomidine a new option for postoperative pain treatment? A meta-analysis of randomized controlled trials. Pain. 2013 Jul;154(7):1140-9. doi: 10.1016/j.pain.2013.03.029. Epub 2013 Mar 27.

  PMID: 23706726 BACKGROUND

• Peng K, Zhang J, Meng XW, Liu HY, Ji FH. Optimization of Postoperative Intravenous Patient-Controlled Analgesia with Opioid-Dexmedetomidine Combinations: An Updated Meta-Analysis with Trial Sequential Analysis of Randomized Controlled Trials. Pain Physician. 2017 Nov;20(7):569-596.

  PMID: 29149140 BACKGROUND

• Zhang X, Wang D, Shi M, Luo Y. Efficacy and Safety of Dexmedetomidine as an Adjuvant in Epidural Analgesia and Anesthesia: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Clin Drug Investig. 2017 Apr;37(4):343-354. doi: 10.1007/s40261-016-0477-9.

  PMID: 27812971 BACKGROUND

• Gerlach AT, Murphy CV, Dasta JF. An updated focused review of dexmedetomidine in adults. Ann Pharmacother. 2009 Dec;43(12):2064-74. doi: 10.1345/aph.1M310.

  PMID: 19934395 BACKGROUND

• Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.

  PMID: 16269301 BACKGROUND

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Trauma, Burns and Surgical Critical Care

Model Details: Prospective, randomized, double-blinded, placebo-controlled trial

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 28, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)