Treatment for rib fractures using cryoneurolysis
Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis for Pain Control (Trauma-PC2-study)
This study is testing a new pain relief method using cold therapy for adults with rib fractures who can’t have surgery to see if it works better than regular pain treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05330611 on ClinicalTrials.gov |
What this trial studies
This research examines the effectiveness of the Iovera Smart Time 190 device for ultrasound-guided cryoneurolysis in trauma patients aged 18-64 with rib fractures who are not candidates for surgical stabilization. The study compares the pain relief outcomes of patients receiving cryoneurolysis of the intercostal nerves against those receiving standard multimodal pain therapy. The goal is to provide both short and long-term pain control while the rib fractures heal.
Who should consider this trial
Good fit: Ideal candidates are trauma patients aged 18 to 64 with acute rib fractures between ribs 3 and 9 and a pain score of 5 or greater.
Not a fit: Patients with rib fractures requiring surgical stabilization or those with contraindications to cryoneurolysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain management for patients with rib fractures, enhancing their recovery experience.
How similar studies have performed: While the use of cryoneurolysis is established, this specific application for rib fractures is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Palo Alto, California
- Stanford Hospital and Clinics — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Joseph D Forrester, MD — Stanford University
- Study coordinator: Alexandra Myers, BA
- Email: amyers19@stanford.edu
- Phone: (650)498-3284
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.