Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis

Launched by STANFORD UNIVERSITY · Apr 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called cryoneurolysis, which is a technique that uses cold to help control pain from rib fractures. The trial is focused on adults aged 18 to 64 who have suffered rib fractures that are not severe enough to require surgery. Researchers want to see if this treatment can provide both short-term and long-term pain relief, allowing patients to heal more comfortably.

To participate in the study, patients must have an acute rib fracture located between the 3rd and 9th ribs and be experiencing significant pain. They should be admitted to Stanford Healthcare's trauma unit for their injuries. However, certain conditions, like severe bleeding problems or specific rib fracture locations, may exclude them from the trial. If eligible, participants can expect to receive the cryoneurolysis treatment, which may help ease their pain while they recover. The Iovera device used in this study has been approved by the FDA, ensuring that it meets safety standards for use.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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.