Interscalene Block and Dysfunction Diaphragmatic: Effect of Low Volume of Ropivacaine 0,1%. A Randomised, Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Compare the occurrence of hemi-diaphragmatic paresis
研究概览
简要总结
The study seeks to show that interscalene injection of a small volume (<8ml) of ropivacaine at a low concentration (0.1%) reduces the frequency of hemi-diaphragmatic paresis compared to low volume injection at the standard concentration (0.5%) in patients undergoing arthroscopic shoulder surgery with ISB.
详细描述
It's a prospective monocentric randomized controlled clinical trial in 2 parallel groups in double blind.
the study concerns patients undergoing arthroscopic shoulder surgery with ISB. The study seeks to show that interscalene injection of a small volume (<8ml) of ropivacaine at a low concentration (0.1%) reduces the frequency of hemi-diaphragmatic paresis compared to low volume injection at the standard concentration (0.5%) in patients undergoing arthroscopic shoulder surgery with ISB.
Randomization in one of the two arms:
- Experimental group: <8ml ropivacaine 0.1%.
- Control group: <8mL of ropivacaine 0.5%.
Evaluation of diaphragmatic stroke by ultrasound and ventilatory function by spirometry and snip test before performing the ISB, then after installation of the ISB.
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
- Double (Participant, Investigator)
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
- •orthopedic surgery compatible with interscalene block
- •french speaking
- •Patient who signed consent to participate in the study
排除标准
- •Pregnant woman
- •ASA score > 3
- •Severe chronic respiratory insufficiency
- •COPD >3 or 4 of Gold score
- •coagulation trouble
- •Allergic to medication involved in the study
- •Breastfeeding women
研究组 & 干预措施
control group : ropivacaine 0.5%
Interscalene block for arthroscopic shoulder surgery with small volume of standard concentration (0.5%) of ropivacaine
干预措施: Ropivacaine 0.5% Injectable Solution (Drug)
Experimental group : ropivacaine 0.1%
Interscalene block for arthroscopic shoulder surgery with small volume of low concentration (0.1%) of ropivacaine
干预措施: Ropivacaine 0.1% Injectable Solution (Drug)
结局指标
主要结局
Compare the occurrence of hemi-diaphragmatic paresis
时间窗: 1h after interscalene block
Hemi diaphragmatic paresis is evaluated by quantifying the homolateral diaphragmatic stroke at interscalene block (ISB) by ultrasound analysis (measured in centimeter), during slow and deep inspiration. Diaphragmatic hemiparesis is defined as a decrease (at post-ISB time vs. pre-ISB time) of more than 25% of the diaphragmatic stroke during this slow and deep inspiration.
次要结局
- Compare the frequency of hemi-diaphragmatic paralysis(1h after interscalene block)
- Compare postoperative analgesia(24 hours postoperatively)
- Compare patient satisfaction(24 to 48 hours postoperatively)
- Compare the ventilatory function (spirometry and snip test).(1h after interscalene block)
- Compare intraoperative analgesia(peroperative time)
- Compare the contralateral diaphragmatic stroke(1h after interscalene block)