Shoulder Disease Clinical Trial
Official title:
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).
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.
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 ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04538690 -
The Effect of Exercise Therapy in Painful Shoulder Disorders
|
N/A | |
| Completed |
NCT04185064 -
Cryopneumatic Device After Shoulder Surgeries
|
N/A | |
| Completed |
NCT03329456 -
MEV to Block the Posterior and Lateral Cords of the Infraclavicular Brachial Plexus
|
Phase 4 | |
| Enrolling by invitation |
NCT04003272 -
MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere
|
||
| Completed |
NCT03956316 -
Short-Term Outcomes of Total Shoulder Arthroplasty Using the Titan Modular Total Shoulder System
|
||
| Recruiting |
NCT04209504 -
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
|
||
| Terminated |
NCT04093700 -
MDR SureLock All-Suture Anchor
|
||
| Completed |
NCT05370872 -
Efficacy of a Remotely Administered Functional Capacity Test on Return-to-work Outcomes
|
N/A | |
| Enrolling by invitation |
NCT06382792 -
Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors
|
||
| Recruiting |
NCT05780229 -
Effectiveness of Treatments for Massive Rotator Cuff Tears: Mixed Methodology.
|
||
| Completed |
NCT03877835 -
Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty
|
N/A | |
| Completed |
NCT06070909 -
Selective Activation of the Infraspinatus During External Rotation Exercises in Participants With Rounded Shoulder Posture
|
||
| Completed |
NCT03393559 -
Effect of Leg Elevation on Prevention of Intraoperative Hypotension During Beach Chair Position
|
N/A | |
| Completed |
NCT05153863 -
C Scope Visualization System Prospective Study
|
N/A | |
| Recruiting |
NCT05302986 -
Effect on Post-operative Pain of Tranexamic Acid Injection During Shoulder Surgery
|
Phase 3 | |
| Recruiting |
NCT06016257 -
Using VirtuaCareTM Platform for Home Programs in Acute and Chronic Shoulder Conditions: A Pilot Study
|
N/A | |
| Recruiting |
NCT06092996 -
Sling vs No Sling After Reverse Total Shoulder Arthroplasty
|
N/A | |
| Enrolling by invitation |
NCT04003311 -
MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head
|
||
| Recruiting |
NCT05284357 -
Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term
|
||
| Enrolling by invitation |
NCT06382779 -
Proximal Humerus Reconstruction After Resection for Tumors : Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite
|