Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWake Forest University Health Sciences
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cryoablation of Intercostal Nerves
- Standard surgical treatment of patients with multiple rib fractures
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov