Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Failure; Respiratory Insufficiency; Trauma; Respiratory Distress Syndrome; Rib Fractures; Rib Fracture Multiple; Pain, Chest; Chest Wall Disorder; Rib Trauma
• Intervention / Treatment: Other: Multi-modal pain regimen; Procedure: Percutaneous Cryoablation of Intercostal Nerves

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Health
      • Contact: Martin G Rosenthal, MD; Phone Number: 909-558-4286; Email: mrosenthal@llu.edu
      • Contact: Matthew E Reeves, MD; Phone Number: 909-558-4289; Email: mareeves@llu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standard multi-modal pain regimen alone	Other: Multi-modal pain regimen; Standard rib fracture protocol including cyclooxygenase inhibitors, anti-neuropathic, muscle relaxers, short term anesthesia interventions (percutaneous block, epidural)
Experimental: Standard multi-modal pain regimen with percutaneous cryoablation	Other: Multi-modal pain regimen; Standard rib fracture protocol including cyclooxygenase inhibitors, anti-neuropathic, muscle relaxers, short term anesthesia interventions (percutaneous block, epidural); Procedure: Percutaneous Cryoablation of Intercostal Nerves; Percutaneous Cryoablation of Intercostal Nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, up to 1 year
Rate of abnormal respiratory mechanics: Incentive Spirometry		Through study completion, up to 1 year
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)	Through study completion, up to 1 year
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	Through study completion, up to 1 year
Quality of Life on Survey	Long Term Quality of Life	Through study completion, up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Pneumonia		Through study completion, up to 1 year
Rate of need for Intubation/Mechanical Ventilation		Through study completion, up to 1 year
Rate of need for tracheostomy		Through study completion, up to 1 year
Number of Ventilatory Days		Through study completion, up to 1 year
ICU Length of Stay		Through study completion, up to 1 year
Hospital Length of Stay		Through study completion, up to 1 year
Acute Respiratory Distress Syndrome		Through study completion, up to 1 year
Rate of Mortality		Through study completion, up to 1 year
Rate of Pleural Space Complications	Hemothorax, Delayed hemothorax, Pneumothorax, Empyema, Hydrothorax, Rate of tube thoracostomy	Through study completion, up to 1 year

Collaborators and Investigators

• Sponsor: Loma Linda University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Trauma; Respiratory Insufficiency; Respiratory Failure; Rib Fractures; Respiratory Distress; Multimodal Pain Therapy; Chest Wall Trauma; Percutaneous Cryoablation; Multimodal Pain Regimen
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Fractures, Bone; Signs and Symptoms, Respiratory; Thoracic Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Respiratory Distress Syndrome; Respiratory Insufficiency; Wounds and Injuries; Dyspnea; Rib Fractures; Chest Pain
• Other Study ID Numbers: 5240003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes