Single Center, Randomized Control Trial of Cryoablation During Surgical Stabilization of Rib Fractures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Morphine Milligram Equivalents Use following Intervention
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The study will blind patients to whether or not they underwent cryoneurolysis
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy
Standard surgical treatment of patients with multiple rib fractures plus Multimodal Pain Therapy
干预措施: Standard surgical treatment of patients with multiple rib fractures (Procedure)
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.
干预措施: Cryoablation of Intercostal Nerves (Device)
结局指标
主要结局
Morphine Milligram Equivalents Use following Intervention
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Day 30
To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.
次要结局
- 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)