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NCT Number: NCT06533904

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.

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Key information

Conditions

Trauma Chest Pain Chest Wall Disorder Dyspnea Fractures, Bone Lung Diseases Neurologic Manifestations Pain Pain, Chest Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Rib Fracture Multiple Rib Fractures Rib Trauma Signs and Symptoms Signs and Symptoms, Respiratory Thoracic Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Cryoablation of Intercostal Nerves

Procedure

Percutaneous Cryoablation of Intercostal Nerves

Multi-modal pain regimen

Other

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

Primary outcomes

  1. Pain Score: Numeric Pain Scale

    Time frame: 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.

  2. Rate of abnormal respiratory mechanics: Incentive Spirometry

    Time frame: Through study completion, up to 1 year

  3. Rate of abnormal respiratory mechanics: Pulmonary Function Tests

    Time frame: 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)

  4. Rate of delirium: Confusion Assessment Method (CAM) Score

    Time frame: 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

  5. Quality of Life on Survey

    Time frame: Through study completion, up to 1 year

    Long Term Quality of Life

Secondary outcomes

  1. Rate of Pneumonia

    Time frame: Through study completion, up to 1 year

  2. Rate of need for Intubation/Mechanical Ventilation

    Time frame: Through study completion, up to 1 year

  3. Rate of need for tracheostomy

    Time frame: Through study completion, up to 1 year

  4. Number of Ventilatory Days

    Time frame: Through study completion, up to 1 year

  5. ICU Length of Stay

    Time frame: Through study completion, up to 1 year

  6. Hospital Length of Stay

    Time frame: Through study completion, up to 1 year

  7. Acute Respiratory Distress Syndrome

    Time frame: Through study completion, up to 1 year

  8. Rate of Mortality

    Time frame: Through study completion, up to 1 year

  9. Rate of Pleural Space Complications

    Time frame: Through study completion, up to 1 year

    Hemothorax, Delayed hemothorax, Pneumothorax, Empyema, Hydrothorax, Rate of tube thoracostomy

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 1, 2024
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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