Shoulder Disease
Conditions
Keywords
continous nerve block, peripheric nerve block, Contiplex Catheter
Brief summary
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
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
Interventions
DEVICECON - 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.
DEVICECTN - 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.
Sponsors
Pontificia Universidad Catolica de Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of insertion | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | compare both groups in terms of level of pain in VAS. |
| Rate of accidental | 72 hrs to evaluate the rate of accidental withdrawal | Accidental withdrawal is the accidental withdrawal of the catheter before 72 hrs after surgery |
Countries
Chile
Outcome results
None listed