Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures

NCT ID: NCT06533904

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-09-30

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.

Conditions

Trauma; Rib Fractures; Chest Wall Disorder; Respiratory Insufficiency; Pain, Chest; Rib Trauma; Rib Fracture Multiple; Respiratory Failure; Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard multi-modal pain regimen alone

Group Type: PLACEBO_COMPARATOR

Multi-modal pain regimen

Intervention Type: OTHER

Standard rib fracture protocol including cyclooxygenase inhibitors, anti-neuropathic, muscle relaxers, short term anesthesia interventions (percutaneous block, epidural)

Standard multi-modal pain regimen with percutaneous cryoablation

Group Type: EXPERIMENTAL

Percutaneous Cryoablation of Intercostal Nerves

Intervention Type: PROCEDURE

Percutaneous Cryoablation of Intercostal Nerves

Multi-modal pain regimen

Intervention Type: OTHER

Standard rib fracture protocol including cyclooxygenase inhibitors, anti-neuropathic, muscle relaxers, short term anesthesia interventions (percutaneous block, epidural)

Interventions

Percutaneous Cryoablation of Intercostal Nerves

Percutaneous Cryoablation of Intercostal Nerves

Intervention Type: PROCEDURE

Multi-modal pain regimen

Standard rib fracture protocol including cyclooxygenase inhibitors, anti-neuropathic, muscle relaxers, short term anesthesia interventions (percutaneous block, epidural)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Loma Linda University Health

Loma Linda, California, United States

Countries

United States

Facility Contacts

Martin G Rosenthal, MD

Role: primary

mrosenthal@llu.edu

909-558-4286

Matthew E Reeves, MD

Role: backup

mareeves@llu.edu

909-558-4289

Other Identifiers

5240003

Identifier Type: -

Identifier Source: org_study_id