What Technique for Caudal Block in Children: Conventional or Ultrasound-guided

NCT ID: NCT06655571

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-03-31

Brief Summary

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The goal of our study is to compare ultrasound-guided caudal block to the conventional technique based on anatomical landmarks.

Detailed Description

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The primary endpoint was the success rate of each technique. We also collected the time taken for each technique, the number of punctures, and the incidence of complications (subcutaneous infiltration, intravascular injection).

Children were randomized to receive a caudal block based on anatomical landmarks (group C) or ultrasound-guided (group E) at a dose of 1 ml/kg of 0.25% bupivacaine, not exceeding 20 ml.

Conditions

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Compare Ultrasound-guided Caudal Block to the Conventional Technique Based on Anatomical Landmarks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

caudal block based on anatomical landmarks (group C) or ultrasound-guided (group E)
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ultrasound

Caudal bloc guided by Ultrasound

Group Type OTHER

Ultrasound guided caudal Block

Intervention Type PROCEDURE

caudal block using Ultrasound

Conventionel

Caudal Block based on anatomical landmarks

Group Type OTHER

Conventionel

Intervention Type PROCEDURE

Caudal Block based on anatomical landmarks

Interventions

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Ultrasound guided caudal Block

caudal block using Ultrasound

Intervention Type PROCEDURE

Conventionel

Caudal Block based on anatomical landmarks

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* children aged between 6 months and 6 years, ASA 1 , underwent elective surgery

Exclusion Criteria

* severe systemic diseases, previous neurological or spinal disorders, coagulation abnormalities, allergies toward LAs, local infection at the block site
Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tunis University

OTHER

Sponsor Role lead

Responsible Party

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Mehdi Trifa

Head of the anesthesia and intensive care department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bechir Hamza hospital

Tunis, Tunis Governorate, Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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salma Aouadi, Hospital university assistant

Role: CONTACT

Facility Contacts

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salma Aouadi

Role: primary

0021656652210

Other Identifiers

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172024

Identifier Type: -

Identifier Source: org_study_id

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