Comparison of Cryoablation of Intercostal Nerves to Erector Spinae Plane Catheters in Patients With Rib Fractures
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Functional Pain Scores
研究概览
简要总结
The purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a ESP catheter.
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 (Outcomes Assessor)
盲法说明
The individual doing the outcome assessments will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are over 18 who have more than one ribs fractured.
排除标准
- •Patients who have an exclusion to regional anesthesia.
- •Patients who are pregnant via self-report or pregnancy test if they take one.
- •Non-English speakers
- •Patients who have cold urticaria
- •Patients with bilateral fractures
- •Patients currently intubated
研究组 & 干预措施
Cryoablation
Participants with rib fracture randomized to Cryoablation.
干预措施: Cryoablation (Drug)
ESP catheter
Participants with rib fracture randomized to ESP Catheter.
干预措施: ESP Catheter (Drug)
结局指标
主要结局
Functional Pain Scores
时间窗: 30 days post procedure
Functional Pain Scores on POD 0,1,2,3,4,5,6,7,and 30
number of patients admitted to ICU
时间窗: 30 days post procedure
number of patients admitted to ICU
Pulmonary Function Testing.
时间窗: 30 days post procedure
Pulmonary Function Tests include spirometry. For patients with pulmonary function testing, the test results between the two groups.
Opioid Use
时间窗: 30 days post procedure
Opioid Use measured in MMEs
Maximum pain score on POD (Post Operative Day) 7
时间窗: 7 days post procedure
Maximum pain score on POD (Post Operative Day) 7
Length of hospital stay
时间窗: 30 days post procedure
Length of hospital stay measured in days:hours:minutes
Number of patients returned home by POD 30
时间窗: 30 days post procedure
Number of patients returned home by POD 30
Number of Patients using opioids at POD 30
时间窗: 30 days post procedure
, Number of Patients using opioids at POD 30
time to first ambulation
时间窗: 30 days post procedure
time to first ambulation measured in days:hours:minutes
number of patients that required mechanical ventilation
时间窗: 30 days post procedure
number of patients that required mechanical ventilation
次要结局
未报告次要终点