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

Last updated: March 28, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Trauma

Treatment

Standard surgical treatment of patients with multiple rib fractures

Cryoablation of Intercostal Nerves

Clinical Study ID

NCT05415384
IRB00084611
  • Ages 18-80
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient is admitted to the trauma service.

  • The patient has multiple displaced rib fractures (≥2 ribs), offered fixation, andconsents 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

Exclusion Criteria:

  • Age < 18 years or ≥ 80 years

  • Flail chest: either radiographic or clinical. Radiographic flail chest is defined onCT chest as ≥ 2 ribs each fractured in ≥ 2 places. Clinical flail is defined asvisualization of a segment of chest wall with paradoxical motion on physical exam.

  • Moderate or severe traumatic brain injury (Intra-cranial hemorrhage visualized on CThead 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 interventionduring this admission

  • The patient was unable to accomplish activities of daily living independently priorto 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 lungisolation or previous pathology

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Standard surgical treatment of patients with multiple rib fractures
Phase:
Study Start date:
August 01, 2022
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

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