Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures

Not Applicable

Not yet recruiting

• Conditions: Rib Trauma; Chest Wall Disorder; Rib Fracture Multiple; Respiratory Failure; Trauma; Rib Fractures; Pain, Chest; Respiratory Distress Syndrome; Respiratory Insufficiency
• Interventions: Device: Percutaneous Cryoablation of Intercostal Nerves; Other: Multi-modal pain regimen

• Registration Number: NCT06533904
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-07-30
• Study First Posted: 2024-08-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Study Start: 2025-06
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard multi-modal pain regimen with percutaneous cryoablation	Percutaneous Cryoablation of Intercostal Nerves	-
Standard multi-modal pain regimen alone	Multi-modal pain regimen	-
Standard multi-modal pain regimen with percutaneous cryoablation	Multi-modal pain regimen	-

Primary Outcome Measures

Name	Time	Method
Rate of abnormal respiratory mechanics: Incentive Spirometry	Through study completion, up to 1 year
Pain Score: Numeric Pain Scale	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	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	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	Through study completion, up to 1 year	Long Term Quality of Life

Secondary Outcome Measures

Name	Time	Method
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	Hemothorax, Delayed hemothorax, Pneumothorax, Empyema, Hydrothorax, Rate of tube thoracostomy

Trial Locations

Locations (1)

Loma Linda University Health; 🇺🇸 Loma Linda, California, United States