Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis
Trial ID or NCT#
Status
RECRUITING
Purpose
The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This will offer patients the benefits of cryoneurolysis of the intercostal nerves, thereby providing short and long term pain control while their ribs heal. The Iovera Smart Tip 190 is FDA approved for cryoneurolysis.
Official Title
Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis for Pain Control (Trauma-PC2-study)
Eligibility Criteria
- - Patients 18 to 64 years with any acute rib fracture between rib 3 and rib 9 - Pain score equal to or greater than 5 with deep inspiration - Presenting and admitted to Stanford Adult Emergency Department, having a trauma consult, and being admitted to the trauma floors of Stanford Healthcare (SHC) for their inpatient stay
- - Radiographic evidence of metastasis to ribs - Glasgow Coma Scale (GCS) score <13 - Patients undergoing SSRF (Surgical stabilization of rib fractures) - Rib fractures located < 3cm from spinous process - Coagulopathy (INR >1.5, Plt < 100) - Other factors precluding cryoneurolysis at the attending's discretion - If only ribs broken are 1,2 or 10,11,12 - Inability to be positioned for the procedure - If the patient has the following conditions that the manufacturer of the Iovera device advises AGAINST using the device if present: Cryoglobulinemia, Paroxysmal cold hemoglobinuria, Cold urticaria, Raynaud's disease, open and/or infected wounds at or near the treatment site.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Sharon Cardenas-Ledezma, BS
650-724-4023
View on ClinicalTrials.gov
