Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis
NCT ID: NCT05330611
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2023-02-21
2026-01-01
Brief Summary
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The Iovera Smart Tip 190 is FDA approved for cryoneurolysis.
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Detailed Description
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Patients in the intervention arm will receive cryoneurolysis via the Iovera device and patients in the control arm will receive standard of care which typically includes multimodal pain therapy and pulmonary toilet. Short and long term pain relief will be compared among both arms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Eligible patients would be enrolled by the trauma service after consent is obtained.
TREATMENT
NONE
Study Groups
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Ultrasound-guided Cryoneurolysis: Group A
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
Cryoneurolysis of Intercostal Nerves
Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190.
The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures.
This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures.
Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
Standard-of-Care : Group B
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
Standard of Care
Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
Interventions
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Cryoneurolysis of Intercostal Nerves
Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190.
The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures.
This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures.
Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
Standard of Care
Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
64 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Joseph Forrester
Assistant Professor of Surgery
Principal Investigators
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Joseph D Forrester, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Ara Ko, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford Hospital and Clinics
Palo Alto, California, United States
Countries
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References
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Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.
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Other Identifiers
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64713
Identifier Type: -
Identifier Source: org_study_id
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