NCT06093776

Rib Fracture Cryoanalgesia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Methodist Health System · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pain Management Improvement

Interventions

Type	Name	Description
DEVICE	ioveraº system	the use of surgical procedure that produces lesions in peripheral nervous tissue through application of extreme cold

Timeline

• Start date: 2023-06-05
• Primary completion: 2025-06-12
• Completion: 2025-06-12
• First posted: 2023-10-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study