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

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Disease
• Intervention / Treatment: Device: CON - Contiplex C™ (CC); Device: CTN - Contiplex

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

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago
    • Santiago de Chile, Santiago, Chile
      • Recruiting
      • Hospital clinico UC christus
      • Contact: alejandro luengo, instructor; Phone Number: +56990951086; Email: ajluengo@uc.cl
      • Contact: Juan cristobal Pedemonte, Asociate Professor; Phone Number: +56223543269; Email: jcpedemo@uc.cl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Estimated): April 24, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: continous nerve block; peripheric nerve block; Contiplex Catheter
• Other Study ID Numbers: 211124003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No