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

October 21, 2024 updated by: Mehdi Trifa, Tunis University
The goal of our study is to compare ultrasound-guided caudal block to the conventional technique based on anatomical landmarks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ultrasound
Caudal bloc guided by Ultrasound
Procedure: Ultrasound guided caudal Block
caudal block using Ultrasound
Other: Conventionel
Caudal Block based on anatomical landmarks
Procedure: Conventionel
Caudal Block based on anatomical landmarks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of block
Time Frame: during surgery
A successful block was defined as an absence of significant motor movements following surgical induction or aberrations in the heart or respiratory rates
during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
block performing time
Time Frame: perioperative
the period between anatomical structures identification and termination of LA administration
perioperative
number of needle puncture
Time Frame: during procedure
during procedure
complication rates
Time Frame: during procedure
Blood aspiration Subcutaneous bulging Bone contact Dural puncture Local anesthetic toxicity
during procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tunis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 172024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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