Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures

Loma Linda University (LLU)

Status: Not yet enrolling

Conditions: Respiratory Distress Syndrome; Respiratory Failure; Rib Fracture Multiple; Pain, Chest; Chest Wall Disorder; Respiratory Insufficiency; Trauma; Rib Fractures; Rib Trauma

Treatments: Procedure: Percutaneous Cryoablation of Intercostal Nerves; Other: Multi-modal pain regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT06533904

5240003

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Standard multi-modal pain regimen alone

Placebo Comparator group

Treatment:

Other: Multi-modal pain regimen

Standard multi-modal pain regimen with percutaneous cryoablation

Experimental group

Treatment:

Other: Multi-modal pain regimen

Procedure: Percutaneous Cryoablation of Intercostal Nerves