University of California, Irvine
Orange, California, 92868, United States
NCT Number: NCT07145346
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Orange, California, 92868, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
o Strong Inhibitors: clarithromycin, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, atazanavir, darunavir, indinavir, lopinavir, telithromycin
The intervention arm will receive oral suzetrigine (100 mg loading dose followed by 50 mg every 12 hours).
The control arm will receive placebo capsules matched to suzetrigine for oral administration.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion of index hospitalization (up to 2 years)
Epidural use - patients that fail pain management will be offered an epidural
Time frame: 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
Time frame: Through study completion of index hospitalization (up to 2 years)
Respiratory complications - include events such as unplanned intubation, pneumonia, pneumothorax and incentive spirometry
Time frame: Through study completion of index hospitalization (up to 2 years)
Mortality - in-hospital mortality rate and 30-day mortality
University of California, Irvine
Other
Suzetrigine for Acute Pain Control in Patients With Multiple Rib Fractures: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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