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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-30

Study Completion Date

2024-07-01

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.

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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

Conditions

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Shoulder Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Contiplex C or CON

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.

Group Type EXPERIMENTAL

CON - Contiplex C™ (CC)

Intervention Type DEVICE

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.

Contiplex or CTN

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.

Group Type ACTIVE_COMPARATOR

CTN - Contiplex

Intervention Type DEVICE

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.

Interventions

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CON - Contiplex C™ (CC)

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.

Intervention Type DEVICE

CTN - Contiplex

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes