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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contiplex C or CON | Experimental | 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. |
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| Contiplex or CTN | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CON - Contiplex Câ„¢ (CC) | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital clinico UC christus | Recruiting | Santiago | Santiago Metropolitan | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29568979 | Background | Nogawa R, Maruyama T, Kimoto Y, Yamazaki A, Kawamata T. Comparison of catheter-over-needle and catheter-through-needle on leakage from the catheter insertion site during continuous femoral nerve block. J Anesth. 2018 Jun;32(3):439-442. doi: 10.1007/s00540-018-2479-7. Epub 2018 Mar 22. | |
| 22565332 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2022 | Jul 21, 2023 | Prot_000.pdf |
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Randomized control trial
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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.
| CTN - Contiplex | 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. |
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Accidental withdrawal is the accidental withdrawal of the catheter before 72 hrs after surgery
| 72 hrs to evaluate the rate of accidental withdrawal |
| Tsui BC, Tsui J. Less leakage and dislodgement with a catheter-over-needle versus a catheter-through-needle approach for peripheral nerve block: an ex vivo study. Can J Anaesth. 2012 Jul;59(7):655-61. doi: 10.1007/s12630-012-9713-9. Epub 2012 May 8. |
| 27107906 | Background | Malik T, Mass D, Cohn S. Postoperative Analgesia in a Prolonged Continuous Interscalene Block Versus Single-Shot Block in Outpatient Arthroscopic Rotator Cuff Repair: A Prospective Randomized Study. Arthroscopy. 2016 Aug;32(8):1544-1550.e1. doi: 10.1016/j.arthro.2016.01.044. Epub 2016 Apr 20. |
| 24043379 | Background | Ip VH, Rockley MC, Tsui BC. The catheter-over-needle assembly offers greater stability and less leakage compared with the traditional counterpart in continuous interscalene nerve blocks: a randomized patient-blinded study. Can J Anaesth. 2013 Dec;60(12):1272-3. doi: 10.1007/s12630-013-0032-6. Epub 2013 Sep 17. No abstract available. |
| 27749354 | Background | Ilfeld BM. Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and Comparison With Novel, Alternative Analgesic Modalities. Anesth Analg. 2017 Jan;124(1):308-335. doi: 10.1213/ANE.0000000000001581. |
| 24645151 | Background | Tsui BC, Ip VH. Catheter-over-needle method reduces risk of perineural catheter dislocation. Br J Anaesth. 2014 Apr;112(4):759-60. doi: 10.1093/bja/aeu066. No abstract available. |