Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures

N/ANot Yet RecruitingNCT06533904

Loma Linda University30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Trauma Rib Fractures Chest Wall Disorder Respiratory Insufficiency

Interventions

Percutaneous Cryoablation of Intercostal NervesPROCEDURE

Percutaneous Cryoablation of Intercostal Nerves

Multi-modal pain regimenOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.