Randomizes Control Trial (RCT): Superiority Study on Inter Scalene Block Execution Time for Shoulder Traumatology Surgery and Non-inferiority for Effectiveness Between Two Block Methods: Catheter Over Needle (CON) vs Catheter Through Needle (CTN).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Time of insertion
研究概览
简要总结
This is a randomized clinical trial with the objective of comparing the time of insertion of two types of perineural catheters in shoulder surgery. These devices are thin lines that have to be inserted over a needle or throw a needle, depending of the type of catheter that is used. The hypothesis is: the installation of Contiplex C or catheter over needle (CON) is faster than a normal contiplex catheter or Catheter throw needle (CTN) at same rate of effectivity.
详细描述
In the market, there is currently two types of catheter to perform a continuous nerve block. One is called Contiplex throw needle catheter that is the most used device and other needle available for performing this block called the Contiplex® C Set, which uses a different method called Catheter over Needle (CON). This method involves advancing the catheter immediately along with the needle upon puncture, and once it reaches the target site, the needle inside the catheter is removed, leaving the catheter in its final working position. This eliminates the step of threading the catheter through the needle. Additionally, this technique allows for the visualization of the final catheter site in vivo with a single operator.
Considering the differences between both techniques, the hypothesis proposed in this study is that in adult patients undergoing shoulder and proximal humerus surgery requiring anesthetic/analgesic management with inter-scalene catheters, the use of the Catheter over Needle (CON) technique results in shorter installation time and similar effectiveness compared to the conventional technique of catheter insertion through the needle (CTN) with tunnel fixation.
The primary objectives will be to compare the block execution times between the CTN and CON techniques, as well as the effectiveness rate of both catheters
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 (Participant)
盲法说明
A list of 72 names, corresponding 36 of them to contiplex C and 36 to regular contiplex will be randomized and will be introduced into sealed envelopes. Before, in order to perform the nerve block the anesthesist will open the envelope and will know wich is the catheter he has to use.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients older than 18 years
- •Rotator cuff or proximal humerus surgery
- •ASA I-III
- •BMI 18-39 kg/m2
- •Acceptance of receiving a peripheric nerve block
排除标准
- •Inability to provide consent for the study
- •Coagulopathy
- •Severe Renal or hepatic disease (Creatinin > 2.0 or Child C)
- •Allergy to local anesthetics
- •Previous peripheral nerve damage
- •Refusal of postoperative continuous block technique
结局指标
主要结局
Time of insertion
时间窗: During Procedure
The time from the insertion of the needle in the skin to: insertion of the catheter and fixation of the tegaderm in the skin
次要结局
- Visual analogue scale (VAS). 0 (minimum) -10 (maximum) points on VAS scale. Lower scores means less pain and higher scores means more pain.(72 hours to determinate the VAS)
- Rate of accidental(72 hrs to evaluate the rate of accidental withdrawal)
研究者
Alejandro Luengo
Clinical professor
Pontificia Universidad Catolica de Chile