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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
Locoregional pain control with cryoneurolysis of intercostal nerves has been employed as an adjunct for longer term pain control. Initially introduced in thoracic surgery, intercostal nerve cryoablation has demonstrated adequate pain control and substantial decrease in opioid consumption and hospital length of stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION | Experimental | Adding Cryoablation of levels 3-8, in addition to patients that undergo SSRF for multiple rib fractures. |
|
| Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy | Active Comparator | Standard surgical treatment of patients with multiple rib fractures plus Multimodal Pain Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation of Intercostal Nerves | Device | Using 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | Day 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. | Day 30 |
| 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. | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days in Hospital Stay | Hospital Length of Stay | Days during admission |
| Number of days in ICU Stay | ICU Length of Stay | Day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bradely W Thomas, MD | Contact | 704-355-3176 | Bradley.Thomas@wfusm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bradely W. Thomas, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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The proposed study is a single center, prospective, randomized controlled trial evaluating the efficacy of adding cryoneurolysis for patients that meet indication for Surgical Stabilization of Rib Fractures (SSRF) and consent to surgical fixation
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The study will blind patients to whether or not they underwent cryoneurolysis
| Standard surgical treatment of patients with multiple rib fractures | Procedure | Standard surgical treatment of patients with multiple rib fractures |
|
| Amount of Chest tube drainage | Chest tube drainage | Day 90 |
| 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 | Month 1 and Month 3 |
| Number of Mortalities in hospital | Mortality, in hospital | Day 90 |
| Number of Readmissions | Readmission | 30 day readmission rate |
| Number of Additional Thoracic Procedures | Additional Thoracic Procedures | Day 7 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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