Completed

NCT Number: NCT06093776

Rib Fracture Cryoanalgesia

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.

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Key information

Conditions

Pain Management Improvement

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ioveraº system

Device

the use of surgical procedure that produces lesions in peripheral nervous tissue through application of extreme cold

Primary outcomes

Pain Assessment

Time frame: 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 outcomes

Demographics

Time frame: 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

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Collaborators

Pacira Pharmaceuticals, Inc

Registry information

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Oct 23, 2023
Registry last updated: Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.