Pain Management Improvement
Conditions
Brief summary
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
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
Interventions
DEVICEioveraº system
the use of surgical procedure that produces lesions in peripheral nervous tissue through application of extreme cold
Sponsors
Methodist Health System
Pacira Pharmaceuticals, Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessment | 14 days | 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 \[15\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographics | 30 days | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORConner McDaniel, MD
Methodist Heath System
Outcome results
None listed