Using cryoablation to improve pain control after rib fracture surgery
Single Center, Randomized Control Trial of Cryoablation During Surgical Stabilization of Rib Fractures
This study is testing if using cryoablation on certain nerves after rib fracture surgery can help patients feel less pain and use fewer pain medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05415384 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of cryoablation of intercostal nerves as an adjunct to surgical stabilization of multiple rib fractures. Patients undergoing surgery for rib fractures will be randomly assigned to receive either cryoablation or standard surgical treatment without cryoablation. The study will assess pain control outcomes, opioid consumption, and hospital length of stay to determine if cryoablation provides superior analgesia. The trial focuses on patients admitted to the trauma service with multiple displaced rib fractures.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with multiple displaced rib fractures who are undergoing surgical stabilization.
Not a fit: Patients with chronic pain conditions, flail chest, or severe traumatic injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance pain management and recovery for patients with rib fractures.
How similar studies have performed: Previous studies have shown that intercostal nerve cryoablation can effectively reduce pain and opioid use in thoracic surgery, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Bradely W. Thomas, MD — Wake Forest University Health Sciences
- Study coordinator: Bradely W Thomas, MD
- Email: Bradley.Thomas@wfusm.edu
- Phone: 704-355-3176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.