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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jun 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether a procedure called cryoablation can help reduce pain more effectively when combined with surgery to stabilize broken ribs. Patients who have multiple broken ribs and are scheduled for surgery may be eligible to participate in this trial. To qualify, participants must be over 18 years old, have at least two displaced rib fractures, and be admitted to the trauma service for treatment, among other criteria.

If you decide to participate, you will be randomly assigned to either receive cryoablation during your rib surgery or to have surgery without this additional treatment. The goal is to see if those who receive cryoablation experience less pain after their surgery compared to those who do not. It’s important to note that certain conditions, such as severe brain injuries or other major injuries, may exclude you from participating. The trial is currently looking for volunteers, so if you meet the criteria and are interested, you can talk to your healthcare provider for more information.

Gender

ALL

Eligibility criteria

• 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