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NCT05415384NARecruiting

Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures

Wake Forest University Health Sciences

Start Date

8/1/2022

Completion Date

11/1/2026

Summary

To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of Surgical Stabilization of Rib Fractures (SSRF) without cryoablation

Detailed Description

Locoregional pain control with cryoneurolysis of intercostal nerves has been employed as an adjunct for longer term pain control. Initially introduced in thoracic surgery, intercostal nerve cryoablation has demonstrated adequate pain control and substantial decrease in opioid consumption and hospital length of stay.

Eligibility Criteria

Age Range: 18 years to 80 years

Inclusion Criteria: * The patient is admitted to the trauma service. * The patient has multiple displaced rib fractures (≥2 ribs), offered fixation, and consents to SSRF * The patient is not being treated for chronic pain * The patient is \>18 years of age. * Surgery anticipated \<120 hours from injury Exclusion Criteria: * Age \< 18 years or ≥ 80 years * Flail chest: either radiographic or clinical. Radiographic flail chest is defined on CT chest as ≥ 2 ribs each fractured in ≥ 2 places. Clinical flail is defined as visualization of a segment of chest wall with paradoxical motion on physical exam. * Moderate or severe traumatic brain injury (Intra-cranial hemorrhage visualized on CT head with GCS at the time of consideration for enrollment \< 12) * Prior or expected emergency exploratory laparotomy during this admission * Prior or expected emergency thoracotomy during this admission * Prior or expected emergency craniotomy during this admission * Spinal cord injury * Pelvic fracture that has required, or is expected to require, operative intervention during this admission * The patient was unable to accomplish activities of daily living independently prior to injury (e.g., dressing, bathing, preparing meals) * The patient is incarcerated * The patient is known to be pregnant * Unable to perform Video Assisted Thoracoscopy (VATS) at time of SSRF due to lung isolation or previous pathology

Interventions

DEVICE

Cryoablation of Intercostal Nerves

PROCEDURE

Standard surgical treatment of patients with multiple rib fractures

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Conditions

Pain, PostoperativeRib Fracture Multiple

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States