Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures
Single Center, Randomized Control Trial of Cryoablation During Surgical Stabilization of Rib Fractures
Wake Forest University Health Sciences
80 participants
Aug 1, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria12
- 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
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Interventions
Using Atricure device, cryoice, intercostal nerves 3-8 will be ablated in the experimental arm. This is in addition to mechanical fixation of rib fractures and multimodal systemic therapy.
Standard surgical treatment of patients with multiple rib fractures
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05415384