Clinical trial NCT05330611: Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis
Official title: Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis for Pain Control (Trauma-PC2-study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rib Fractures
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We are proposing a prospective, randomized trial evaluating efficacy of ultrasound-guided cryoneurolysis for pain control after traumatic rib fractures in patients 18-64 years of age.

Eligible patients would be enrolled by the trauma service after consent is obtained.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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.

Primary outcomes:
measure: Daily Numeric Pain Score
timeFrame: 12 months
measure: Length of hospital stay
timeFrame: Up to 1 month
measure: Daily Narcotic Equivalents
timeFrame: 12 Months
Secondary outcomes:
measure: 30-day mortality
timeFrame: 1 month
measure: Need for ICU admission
timeFrame: 1 month
measure: 30-day rib-specific admission
timeFrame: 1 month
measure: The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
timeFrame: 30 days, 90 days, 365 days
measure: The Glasgow Outcome Scale Extended (GOS-E) Score
timeFrame: 30 days, 90 days, 365 days
measure: Short Form (SF-12) Health Survey Scale Score
timeFrame: 30 days, 90 days, 365 days
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Joseph D Forrester, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Ara Ko, MD
role: PRINCIPAL_INVESTIGATOR
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