Status:
RECRUITING
Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Pain, Postoperative
Rib Fracture Multiple
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 cryoablati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05415384
Start Date
August 1 2022
End Date
September 1 2026
Last Update
March 30 2025
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157