Catheter Over Needle (CON) vs Catheter Through Needle (CTN).

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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).

Conditions
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Shoulder Disease

Intervention / Treatment
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* Device: CON - Contiplex C™ (CC)
* Device: CTN - Contiplex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Inability to provide consent for the study Coagulopathy Sepsis 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contiplex C or CON<br>Patients who will receive a contiplex C block for interscalene nerve block. This catheter also calls Catheter over needle (CON), wich is a catheter that is inserted at the same time that the needle is advancing. | Device: CON - Contiplex C™ (CC)<br>* This is a catheter used for peripherical nerve block that is inserted at the same time that the needle is being introduced. When the target is achieved, the needle is retired.<br>|
| Active Comparator: Contiplex or CTN<br>Patients who will receive a regular contiplex block for interscalene nerve block or also called Catheter throw needle (CTN). This catheter is the gold standard in this centre and the mechanism of insertion is to introduce the catheter throw the needle. | Device: CTN - Contiplex<br>* This is the traditional catheter used in this centre for peripheric nerve block. In this catheter the needle is introduced first. When the target is achieved the catheter is then introduced throw the needle and after that the needle is retired.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of insertion | The time from the insertion of the needle in the skin to: insertion of the catheter and fixation of the tegaderm in the skin | During Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS). 0 (minimum) -10 (maximum) points on VAS scale. Lower scores means less pain and higher scores means more pain. | compare both groups in terms of level of pain in VAS. | 72 hours to determinate the VAS | 
| Rate of accidental | Accidental withdrawal is the accidental withdrawal of the catheter before 72 hrs after surgery | 72 hrs to evaluate the rate of accidental withdrawal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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continous nerve block, peripheric nerve block, Contiplex Catheter