Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures

NCT06533904 | Not Yet Recruiting

• 1 other identifier: 5240003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

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

Keywords

Trauma; Respiratory Failure; Respiratory Distress; Respiratory Insufficiency; Rib Fractures; Chest Wall Trauma; Percutaneous Cryoablation; Multimodal Pain Therapy; Multimodal Pain Regimen

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (9)

• 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

Study Arms (2)

Standard multi-modal pain regimen alone

PLACEBO COMPARATOR

Other: Multi-modal pain regimen

Standard multi-modal pain regimen with percutaneous cryoablation

EXPERIMENTAL

Procedure: Percutaneous Cryoablation of Intercostal Nerves; Other: Multi-modal pain regimen

Interventions

Percutaneous Cryoablation of Intercostal Nerves PROCEDURE

Percutaneous Cryoablation of Intercostal Nerves

Standard multi-modal pain regimen with percutaneous cryoablation

Multi-modal pain regimen OTHER

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

Standard multi-modal pain regimen alone; Standard multi-modal pain regimen with percutaneous cryoablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years old
• \> 2 rib fractures
• Verbal Pain score \> 5
• Incentive Spirometry \< 60% of predicted

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Rib Fractures; Respiratory Insufficiency; Chest Pain; Respiratory Distress Syndrome; Dyspnea

Condition Hierarchy (Ancestors)

Fractures, Bone; Thoracic Injuries; Respiration Disorders; Respiratory Tract Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Signs and Symptoms, Respiratory

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to standard multi-modal pain regimen with percutaneous cryoablation versus standard multi-modal pain regimen alone.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)