Interfascial Blocks Executed by Novice Operators in a Simulator Model: a Comparison of Two Types of Needles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Time to correct block execution
研究概览
简要总结
This study will compare two different needles for interfascial blocks. All participants will execute the block on simulator with both needles. The participants will be randomized in two groups to choose the starting needle.
详细描述
Interfascial blocks are an emerging field of anesthesia. They are executed injecting local anesthetics inside a fascia plane using a needle.
Actually no evidence supports the use of a needle upon one other. Investigators would like to compare "Ultraplex 360®" (Braun) needle with " STIMUPLEX D SH, 30°"(Braun) while performing a Trasversus Abdominis Plane Block on BluePhantom simulator.
Ultraplex 360® (Braun) has an innovative surface pattern and clear coating that could result in better ultrasound visualization and tip identification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Novice interfascial block operators (< 15 interfascial blocks executed)
- •informed consent
排除标准
- •Exper Interfascial blocks operators
研究组 & 干预措施
"Ultraplex 360"
This group will execute the first TAP block using "Ultraplex 360" (Braun) and the second TAP block using " STIMUPLEX D SH, 30°" (Braun)
干预措施: Ultraplex 360(Braun) (Device)
" STIMUPLEX D SH, 30°"
This group will execute the first TAP block using " STIMUPLEX D SH, 30°" (Braun) and the second TAP block using "Ultraplex 360" (Braun)
干预措施: STIMUPLEX D SH, 30°(Braun) (Device)
结局指标
主要结局
Time to correct block execution
时间窗: baseline
Investigators will measure time needed to correctly perform the block in seconds. The chronometer will be started when the participant takes the ultrasound probe and will be stopped when 10 ml saline has been fully injected.
次要结局
- Needle tip visualization(baseline)
- Participant Overall Satisfaction(baseline)
研究者
Alessandro De Cassai
Principal Investigator
University of Padova