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Recruiting

NCT Number: NCT06655571

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

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

Recruiting

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Key information

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bechir Hamza hospital

Tunis, Tunis Governorate, 2001, Tunisia

Location status: Recruiting

Location contact

salma Aouadi

CONTACT

[email protected]

0021656652210

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound Guided Caudal Block

Procedure

caudal block using Ultrasound

Conventionel

Procedure

Caudal Block based on anatomical landmarks

Primary outcomes

  1. 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

Secondary outcomes

  1. block performing time

    Time frame: perioperative

    the period between anatomical structures identification and termination of LA administration

  2. number of needle puncture

    Time frame: during procedure

  3. complication rates

    Time frame: during procedure

    Blood aspiration Subcutaneous bulging Bone contact Dural puncture Local anesthetic toxicity

Study contacts

Contact information is provided by the study sponsor or research team.

salma Aouadi, Hospital university assistant

CONTACT

[email protected]

56652210

Sponsors and collaborators

Lead sponsor

Tunis University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.