Rib Fracture Cryoanalgesia

Recruiting

• Conditions: Pain Management Improvement

• Registration Number: NCT06093776
• Lead Sponsor: Methodist Health System

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

Study Timeline

• Study Start: 2023-06-05
• Status Verified: 2023-07
• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-10-17
• Last Update Submitted: 2023-10-17
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-06-05
• Study Completion: 2025-06-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States