Clinical trial NCT06533904: Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures
Official title: Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma
Rib Fractures
Chest Wall Disorder
Respiratory Insufficiency
Pain, Chest
Rib Trauma
Rib Fracture Multiple
Respiratory Failure
Respiratory Distress Syndrome
Keywords: Trauma
Respiratory Failure
Respiratory Distress
Respiratory Insufficiency
Rib Fractures
Chest Wall Trauma
Percutaneous Cryoablation
Multimodal Pain Therapy
Multimodal Pain Regimen
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients will be randomized to standard multi-modal pain regimen with percutaneous cryoablation versus standard multi-modal pain regimen alone.
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Pain Score: Numeric Pain Scale
timeFrame: Through study completion, up to 1 year
measure: Rate of abnormal respiratory mechanics: Incentive Spirometry
timeFrame: Through study completion, up to 1 year
measure: Rate of abnormal respiratory mechanics: Pulmonary Function Tests
timeFrame: Through study completion, up to 1 year
measure: Rate of delirium: Confusion Assessment Method (CAM) Score
timeFrame: Through study completion, up to 1 year
measure: Quality of Life on Survey
timeFrame: Through study completion, up to 1 year
Secondary outcomes:
measure: Rate of Pneumonia
timeFrame: Through study completion, up to 1 year
measure: Rate of need for Intubation/Mechanical Ventilation
timeFrame: Through study completion, up to 1 year
measure: Rate of need for tracheostomy
timeFrame: Through study completion, up to 1 year
measure: Number of Ventilatory Days
timeFrame: Through study completion, up to 1 year
measure: ICU Length of Stay
timeFrame: Through study completion, up to 1 year
measure: Hospital Length of Stay
timeFrame: Through study completion, up to 1 year
measure: Acute Respiratory Distress Syndrome
timeFrame: Through study completion, up to 1 year
measure: Rate of Mortality
timeFrame: Through study completion, up to 1 year
measure: Rate of Pleural Space Complications
timeFrame: Through study completion, up to 1 year
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
References: