Single Center, Randomized Control Trial of Cryoablation During Surgical Stabilization of Rib Fractures
Overview
- Phase
- N/A
- Intervention
- Cryoablation of Intercostal Nerves
- Conditions
- Pain, Postoperative
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Morphine Milligram Equivalents Use following Intervention
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION
Adding Cryoablation of levels 3-8, in addition to patients that undergo SSRF for multiple rib fractures.
Intervention: Cryoablation of Intercostal Nerves
Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy
Standard surgical treatment of patients with multiple rib fractures plus Multimodal Pain Therapy
Intervention: Standard surgical treatment of patients with multiple rib fractures
Outcomes
Primary Outcomes
Morphine Milligram Equivalents Use following Intervention
Time Frame: Day 90
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Morphine Milligram Equivalents Use following Intervention
Time Frame: Baseline
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Morphine Milligram Equivalents Use following Intervention
Time Frame: Day 1
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Morphine Milligram Equivalents Use following Intervention
Time Frame: Day 30
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
Secondary Outcomes
- Number of days in ICU Stay(Day 90)
- Amount of Chest tube drainage(Day 90)
- Quality of Life Scores(Month 1 and Month 3)
- Number of days in Hospital Stay(Days during admission)
- Number of Mortalities in hospital(Day 90)
- Number of Readmissions(30 day readmission rate)
- Number of Additional Thoracic Procedures(Day 7)