Pain, Postoperative, Rib Fracture Multiple
Conditions
Keywords
Locoregional pain, thoracotomy
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
Detailed description
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.
Interventions
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.
PROCEDUREStandard surgical treatment of patients with multiple rib fractures
Standard surgical treatment of patients with multiple rib fractures
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The study will blind patients to whether or not they underwent cryoneurolysis
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Milligram Equivalents Use following Intervention | Baseline | To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days in Hospital Stay | Days during admission | Hospital Length of Stay |
| Number of days in ICU Stay | Day 90 | ICU Length of Stay |
| Amount of Chest tube drainage | Day 90 | Chest tube drainage |
| Quality of Life Scores | Month 1 and Month 3 | 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 |
| Number of Mortalities in hospital | Day 90 | Mortality, in hospital |
| Number of Readmissions | 30 day readmission rate | Readmission |
| Number of Additional Thoracic Procedures | Day 7 | Additional Thoracic Procedures |
Countries
United States
Contacts
CONTACTBradely W Thomas, MD
PRINCIPAL_INVESTIGATORBradely W. Thomas, MD
Wake Forest University Health Sciences
Outcome results
None listed