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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Cryoablation of Intercostal Nerves
DeviceUsing Atricure device, cryoice, intercostal nerves 3-8 will be ablated in the experimental arm. This is in addition to mechanical fixation of rib fractures and multimodal systemic therapy.
Standard surgical treatment of patients with multiple rib fractures
Procedure/SurgeryStandard surgical treatment of patients with multiple rib fractures
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATIONExperimental treatment 1 intervention
Group B: Surgical Stabilization of Rib Fractures plus Multimodal Pain TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Morphine Milligram Equivalents Use following Intervention
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Time frame
Baseline2
Morphine Milligram Equivalents Use following Intervention
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Time frame
Day 13
Morphine Milligram Equivalents Use following Intervention
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Time frame
Day 304
Morphine Milligram Equivalents Use following Intervention
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Time frame
Day 90Secondary outcomes
1
Number of days in Hospital Stay
Hospital Length of Stay
Time frame
Days during admission2
Number of days in ICU Stay
ICU Length of Stay
Time frame
Day 903
Amount of Chest tube drainage
Chest tube drainage
Time frame
Day 904
Quality of Life Scores
Quality of Life questionnaire - Quality of life questionnaire consists of a set of survey questions that can be used to collect data related to an individual in particular and society in general on various parameters that determine their general quality of life
Time frame
Month 1 and Month 3Sponsors and contacts
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Source ClinicalTrials.gov