At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓1-6 rib fractures (total bilateral) sustained within 3 days, at least 3 cm distal to costo-transverse joint
- ✓Regional anesthetic requested by admitting service
- ✓Patient accepting of cryoneurolysis procedure
- ✕Chronic opioid use (daily use ≥2 weeks prior and duration >4 weeks)
- ✕Pregnancy
- ✕Flail chest
- ✕Chest tube in place
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intercostal Cryoneurolysis Following Traumatic Rib Fractures
In Brief
A Phase 4 clinical trial evaluating Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas), Intercostal nerve block ropivacaine with epinephrine, and 2 other interventions for Traumatic Rib Fracture(s). Completed, enrolled 20 participants across 1 site.
Detailed Summary
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 multicenter, randomized, double-masked, sham-controlled, parallel-arm study is to evaluate the potential of cryoanalgesia to decrease pain and improve pulmonary mechanics in patients with rib fractures.
Study Details
Timeline
Interventions
The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.
3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block(s)
The cryoneurolysis device will be triggered using 2 cycles of 2-minute gas activation separated by 1-minute defrost periods. For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
3 mL of normal saline will be injected perineurally to provide placebo intercostal nerve blocks