Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis

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Trial ID: NCT05330611

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)

Stanford Investigator(s)

Joseph (Joe) D Forrester MD MSc FAWM FACS
Joseph (Joe) D Forrester MD MSc FAWM FACS

Assistant Professor of Surgery (General Surgery)

Eligibility


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.

Intervention(s):

device: Cryoneurolysis of Intercostal nerves

other: Standard of Care

Recruiting

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sharon Cardenas-Ledezma, BS
650-724-4023