Intercostal Cryoneurolysis Following Traumatic Rib Fractures
Stopped early · Not applicable · Has a placebo group
Conditions studied: Rib Fractures
In brief
Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to pulmonary complications and a high degree of morbidity and mortality. Peripheral nerve blocks as well as epidural blocks have been used with success to improve pain control in rib fracture patients and have been associated with decreased pulmonary complications and improved outcomes. However, a single-injection nerve block lasts less than 24 hours; and, even a continuous nerve block is generally limited to 3-4 days. The pain from rib fractures usually persists for multiple weeks or months. In contrast to local anesthetic-induced nerve blocks, a prolonged block lasting a few weeks/months may be provided by freezing the nerve using a process called "cryoneurolysis". The goal of this randomized, double-masked, sham-controlled study is to evaluate the potential of cryoanalgesia to decrease pain and improve pulmonary mechanics in patients with rib fractures.
Key facts
- Study ID
- NCT03917823
- Run by
- University of California, San Diego
- People needed
- 4
- Starts
- 2019-04-20
- Expected to finish
- 2020-03-25
- Last updated by the study team
- 2021-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients of at least 18 years of age
- having 1-3 sustained rib fractures on either or both sides (if bilateral fractures, then total up to 6 fractures with up to 3 per side)
- regional anesthetic requested by the admitting service
- accepting of a cryoneurolysis procedure
You may not qualify if…
- chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks
- pregnancy
- incarceration
- inability to communicate with the investigators
- morbid obesity (body mass index > 40 kg/m2)
- possessing any contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria and Reynaud's Syndrome
- any patient unable to correctly perform incentive spirometry as this is an outcome measure
- any patient with any degree of decreased mental capacity as determined by the surgical service
- any reason an investigator believes study participation would not be in the best interest of the potential subject, including an anti-coagulated state
Where it is running
- University California San Diego — San Diego, California, United States
Full record on ClinicalTrials.gov
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