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临床试验/NCT06299137
NCT06299137已完成早期 1 期

Ultrasound Guided Serratus Anterior Plane Block in ED Patients With Rib Fractures,

Rhode Island Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
40
试验地点
1
主要终点
PIC Score

研究概览

简要总结

The goal of this clinical trial is to test the effectiveness of the Serratus Anterior Plane Block in patients with rib fractures. The main questions it aims to answer are:

  • Determine if UG-SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours.
  • Evaluate if UG-SAPB results in fewer opioid medications administered when compared to usual care over the first 24 hours.

Participants will undergo the Serratus Anterior Plane. Researchers will compare this to usual care to see if this intervention improves pulmonary function and reduces opioid requirements for ED patients with rib fractures.

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

Research Assistants who collect the data will be blinded to which arm of the study the participants are in.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Radiology confirmed anterior or lateral rib fractures either on X-ray or chest computed tomography CT
  • pain score of 5/
  • Patients must be able to verbalize how much pain they are having on an 11-point Numeric Rating Pain Scale
  • perform an incentive spirometry and be able to cough on command

排除标准

  • isolated rib fractures that do not include ribs T3-T9
  • penetrating trauma, pregnancy
  • requiring immediate surgical or procedural intervention
  • known allergy to amide-type local anesthetics
  • have a painful distracting injury

研究组 & 干预措施

Intervention arm (Undergoes SAPB)

Experimental

Patients randomized to this arm will receive the Serratus Anterior Plane block.

干预措施: Serratus Anterior Plane Block (Procedure)

Intervention arm (Undergoes SAPB)

Experimental

Patients randomized to this arm will receive the Serratus Anterior Plane block.

干预措施: Ropivacaine injection (Drug)

Control

No Intervention

Usual care. No changes made or recommended to patients randomized to the control arm.

结局指标

主要结局

PIC Score

时间窗: 5 hours

Determine if the SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours. The PIC score is a scoring system that can be measured serially in patients with rib fractures to assess pulmonary function and to prognosticate clinical outcomes.

次要结局

  • Total oral morphine equivalents over the first 24 hours(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leland Perice

Principal Investigator

Rhode Island Hospital

研究点 (1)

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