About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
> 18 years old
> 2 rib fractures
Verbal Pain score > 5
Incentive Spirometry < 60% of predicted
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Percutaneous Cryoablation of Intercostal Nerves
Procedure/SurgeryPercutaneous Cryoablation of Intercostal Nerves
Multi-modal pain regimen
Other interventionStandard rib fracture protocol including cyclooxygenase inhibitors, anti-neuropathic, muscle relaxers, short term anesthesia interventions (percutaneous block, epidural)
Treatment groups
Trial outcomes
Primary outcomes
Pain Score: Numeric Pain Scale
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 abnormal respiratory mechanics: Incentive Spirometry
Rate of abnormal respiratory mechanics: Pulmonary Function Tests
Short and Long Term Respiratory Mechanics. Pulmonary Function Tests will specifically measure Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC)
Rate of delirium: Confusion Assessment Method (CAM) Score
The score ranges from 0 to 19. Where higher scores indicate more severe delirium and low scores indicate less severe or no delirium
Secondary outcomes
Rate of Pneumonia
Rate of need for Intubation/Mechanical Ventilation
Rate of need for tracheostomy
Number of Ventilatory Days
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: