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临床试验/NCT06347874
NCT06347874
招募中
4 期

Comparison of Cryoablation of Intercostal Nerves to Erector Spinae Plane Catheters in Patients With Rib Fractures

University of Minnesota1 个研究点 分布在 1 个国家目标入组 48 人2025年1月10日

概览

阶段
4 期
干预措施
Cryoablation
疾病 / 适应症
Rib Fractures
发起方
University of Minnesota
入组人数
48
试验地点
1
主要终点
Functional Pain Scores
状态
招募中
最后更新
2个月前

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.

注册库
clinicaltrials.gov
开始日期
2025年1月10日
结束日期
2027年3月13日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

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

ESP catheter

Participants with rib fracture randomized to ESP Catheter.

干预措施: ESP Catheter

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

研究点 (1)

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