Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures
Overview
- Phase
- Not Applicable
- Intervention
- Multi-modal pain regimen
- Conditions
- Trauma
- Sponsor
- Loma Linda University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Rate of abnormal respiratory mechanics: Incentive Spirometry
- Status
- Not yet recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Standard multi-modal pain regimen alone
Intervention: Multi-modal pain regimen
Standard multi-modal pain regimen with percutaneous cryoablation
Intervention: Percutaneous Cryoablation of Intercostal Nerves
Standard multi-modal pain regimen with percutaneous cryoablation
Intervention: Multi-modal pain regimen
Outcomes
Primary Outcomes
Rate of abnormal respiratory mechanics: Incentive Spirometry
Time Frame: Through study completion, up to 1 year
Pain Score: Numeric Pain Scale
Time Frame: Through study completion, up to 1 year
Short and Long Term Pain Scores. Range from 0 to 10 where 0 is no pain and 10 is most severe and worse outcome.
Rate of delirium: Confusion Assessment Method (CAM) Score
Time Frame: Through study completion, up to 1 year
The score ranges from 0 to 19. Where higher scores indicate more severe delirium and low scores indicate less severe or no delirium
Rate of abnormal respiratory mechanics: Pulmonary Function Tests
Time Frame: Through study completion, up to 1 year
Short and Long Term Respiratory Mechanics. Pulmonary Function Tests will specifically measure Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC)
Quality of Life on Survey
Time Frame: Through study completion, up to 1 year
Long Term Quality of Life
Secondary Outcomes
- Rate of need for tracheostomy(Through study completion, up to 1 year)
- ICU Length of Stay(Through study completion, up to 1 year)
- Acute Respiratory Distress Syndrome(Through study completion, up to 1 year)
- Rate of Pneumonia(Through study completion, up to 1 year)
- Rate of need for Intubation/Mechanical Ventilation(Through study completion, up to 1 year)
- Hospital Length of Stay(Through study completion, up to 1 year)
- Number of Ventilatory Days(Through study completion, up to 1 year)
- Rate of Mortality(Through study completion, up to 1 year)
- Rate of Pleural Space Complications(Through study completion, up to 1 year)