Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis (Trauma-PC2)

Stanford University

Status: Completed

Conditions: Rib Fractures

Treatments: Device: Cryoneurolysis of Intercostal Nerves; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05330611

64713

Details and patient eligibility

About

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.

Full description

The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for minimally invasive ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This procedure will offer patients the benefits of cryoneurolysis (freezing) of the intercostal nerves, thereby providing short and long term pain control while their ribs heal.

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Ultrasound-guided Cryoneurolysis: Group A

Experimental group

Description:

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

Treatment:

Device: Cryoneurolysis of Intercostal Nerves

Standard-of-Care : Group B

Active Comparator group

Description:

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.

Treatment:

Other: Standard of Care