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

NCT05960799 | Recruiting DMC

• 1 other identifier: 211124003
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Disease

Keywords

continous nerve block; peripheric nerve block; Contiplex Catheter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Rate of accidental

  72 hrs to evaluate the rate of accidental withdrawal

Study Arms (2)

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.

Device: CON - Contiplex C™ (CC)

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.

Device: CTN - Contiplex

Interventions

CON - Contiplex C™ (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.

Contiplex C or CON

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.

Contiplex or CTN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital clinico UC christus

Santiago, Santiago Metropolitan, Chile

RECRUITING

Related Publications (6)

• 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.

  PMID: 29568979 BACKGROUND

• 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.

  PMID: 22565332 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.

  PMID: 27107906 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.

  PMID: 24043379 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.

  PMID: 27749354 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.

  PMID: 24645151 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Model Details: Randomized control trial

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 27, 2023
• Study Start: October 30, 2023
• Primary Completion: April 24, 2024
• Study Completion: July 1, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)