Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06093776
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-07-26
Brief Title:
Rib Fracture Cryoanalgesia
Sponsor:
Methodist Health System
Organization:
Methodist Health System
Study Overview
Official Title:
Rib Fracture Cryoanalgesia
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None