NCT05415384 Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures
| NCT ID | NCT05415384 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Pain, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2022-08-01 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Bradely W. Thomas, MD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT05415384 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Pain, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05415384 currently recruiting?
Yes, NCT05415384 is actively recruiting participants. Contact the research team at Bradley.Thomas@wfusm.edu for enrollment information.
Where is the NCT05415384 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT05415384 clinical trial?
NCT05415384 is sponsored by Wake Forest University Health Sciences. The principal investigator is Bradely W. Thomas, MD at Wake Forest University Health Sciences. The trial plans to enroll 80 participants.