Rib Fracture Cryoanalgesia

Study Overview
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Brief Summary
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Rib fractures lead to poor patient outcomes and even death 3. Data suggests effective pain management is crucial to obtain favorable outcomes 4, 5Current outpatient treatment modalities are limited to oral or topical medications with low efficacy and high risk for opioid dependence. In-patient management with a thoracic epidural TEA is largely considered the gold standard, but the risks of TEA may outweigh the benefits 6 to 8.

Detailed Description
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Methodist Dallas Medical Center MDMC is an urban Level I Trauma Center that manages over 200 rib fracture cases annually. MDMC has a history of developing and using innovative analgesia techniques aimed at improving outcomes. In 2010 we first described the need for advancements in the treatment of rib fracture patients 1. Later, we validated the technique that is now used at hundreds of trauma centers around the world 2. Our surgical and research teams have a history of advocating for optimal management of rib fracture pain in order to prevent serious complications. This study will seek to describe the effective use of cryoanalgesia as a feasible method of pain management in the rib fracture patient. With a small cohort and case series, we will describe and refine the procedure and preliminary efficacy of the FDA-approved iovera system in adult rib fracture patients. In order to ethically assess the clinical relevance of the iovera system, our objective will be accomplished by completing a case series

Official Title
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Rib Fracture Cryoanalgesia

Conditions
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Pain Management Improvement

Intervention / Treatment
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* Device: ioveraº system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age Acute pain attributed to rib fracture(s) Able to obtain consent Exclusion Criteria: <18 years of age Pregnant Incarcerated Confounding injuries or significant pain attributed to secondary injury Patients with any of the following: cryoglobulinemia; paroxysmal cold hemoglobinuria; cold urticarial; Raynaud's disease; open and/or infected wounds at or near the treatment site

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case Series<br>Prospective: Case Series The investigators will complete ioveraº system training (i.e., cadaveric demonstration) and work with our local surgical team to develop an effective procedure. The technique will then be refined and considered fully developed with three consecutive successful placements. Data reporting to the sponsor will occur once data for the first five successful interventions and the subsequent 14-day follow-ups are completed. Adverse event reporting to the IRB will occur in accordance with GCP standards. Due to the small sample size and short duration, patients lost to follow-up will be an indication for additional enrollment. No more than 10 total subjects will be enrolled. | Device: ioveraº system<br>* the use of surgical procedure that produces lesions in peripheral nervous tissue through application of extreme cold<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment | Pain assessment using the Numeric Rating Scale for Pain NRS Pain McGill Pain Questionnaire [MPQ]), hospital LOS, ICU LOS, ventilator days, pain interference (using the Brief Pain Inventory [BPI]), sleep interference (using the Medical Outcomes Sleep Scale [MOS-Sleep]), sleep quality (using the Pittsburgh Sleep Quality Index [PSQI]), quality of life assessment [14], adverse events, re-admissions, and patient satisfaction [15]. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics | Demographics age, sex, ethnicity, injury characteristics injury severity score ISS, abbreviated injury scale [AIS], mechanism, cause of injury), comorbidities, diagnoses, procedures, Glasgow Coma Scale (GCS) score (eye, verbal, motor, total), discharge status, discharge condition, emergency department and admission vitals, medication | 30 days |