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NCT06533904 | NOT YET RECRUITING | Trauma

Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures
Sponsor:

Loma Linda University

Brief Summary:

The goal of this double blinded randomized control trial is to learn if percutaneous cryoablation of traumatic rib fractures improves outcomes. The main questions it aims to answer are: Does percutaneous cryoablation improve short and long term pain scores? Does percutaneous cryoablation improve short and long term respiratory mechanics? Does percutaneous cryoablation improve long term quality of life? Does percutaneous cryoablation decrease delirium? Researchers will compare cryoablation to standard multimodal pain therapy to see if this impacts respiratory recovery. Participants will undergo randomization, percutaneous cryoablative procedure, and participate in tests at pre-determined intervals to evaluate their pulmonary recovery.

Condition or disease

Trauma

Rib Fractures

Chest Wall Disorder

Respiratory Insufficiency

Pain, Chest

Rib trauma

Rib Fracture Multiple

Respiratory Failure

Respiratory Distress Syndrome

Intervention/treatment

Percutaneous Cryoablation of Intercostal Nerves

Multi-modal pain regimen

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2026-07-31
Estimated Study Completion Date : 2026-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * \> 18 years old
  • * \> 2 rib fractures
  • * Verbal Pain score \> 5
  • * Incentive Spirometry \< 60% of predicted
Exclusion Criteria
  • * Isolated Fractures of Ribs 1-3 and/or 10-12
  • * Posterior Rib Fracture \< 4 cm from costovertebral joint
  • * Sternal, Clavicle, Scapula Fracture
  • * Thoracic Spinal Fracture of any type
  • * Open Abdominothoracic Surgery
  • * Unstable Spine
  • * Extensive Subcutaneous Emphysema
  • * BMI \> 35
  • * Plan for Rib Plating
  • * Chronic Opioid Use
  • * Prior to study enrollment: Intubated, Traumatic Brain Injury, Dementia, Cognitive Impairment, Encephalopathy
  • * Coagulopathy, Shock at time of ablation
  • * Inability to participate in activities of daily living prior to injury
  • * Home O2 use prior to trauma
  • * Inhalation Injury
  • * Rib Fractures due to cardiopulmonary resuscitation
  • * Life Expectancy \< 6 months
  • * \> 48 hours from injury
  • * Pregnant, Incarcerated
Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures

Location Details

NCT06533904

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Locations

Not yet recruiting

United States, California

Loma Linda University Health

Loma Linda, California, United States, 92354