Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Single Center, Randomized Control Trial of Cryoablation During Surgical Stabilization of Rib Fractures

Conditions
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Pain, Postoperative, Rib Fracture Multiple

Intervention / Treatment
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* Device: Cryoablation of Intercostal Nerves
* Procedure: Standard surgical treatment of patients with multiple rib fractures


Participation Criteria
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Eligibility Criteria
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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 <72 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION<br>Adding Cryoablation of levels 3-8, in addition to patients that undergo SSRF for multiple rib fractures. | Device: Cryoablation of Intercostal Nerves<br>* 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.<br>|
| Active Comparator: Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy<br>Standard surgical treatment of patients with multiple rib fractures plus Multimodal Pain Therapy | Procedure: Standard surgical treatment of patients with multiple rib fractures<br>* Standard surgical treatment of patients with multiple rib fractures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locoregional pain, thoracotomy