RecruitingNot ApplicableNCT05960799

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

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).


Sponsor

Pontificia Universidad Catolica de Chile

Enrollment

70 participants

Start Date

Oct 30, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

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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.


Locations(1)

Hospital clinico UC christus

Santiago, Santiago Metropolitan, Chile

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NCT05960799


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