Rib Fractures
Conditions
Keywords
blunt chest trauma, rib fractures, Suzetrigine, multimodal pain regimen
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.
Interventions
The intervention arm will receive oral suzetrigine (100 mg loading dose followed by 50 mg every 12 hours).
DRUGPlacebo
The control arm will receive placebo capsules matched to suzetrigine for oral administration.
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
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.
Intervention model description
Prospective, randomized, double-blinded, placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed