NCT06655571

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

October 21, 2024

Last Update Submit

October 21, 2024

Conditions

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

Keywords

caudal block - children - ultrasound - conventional method

Outcome Measures

Primary Outcomes (1)

  • Success rate of block

    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 Outcomes (3)

  • block performing time

    perioperative

  • number of needle puncture

    during procedure

  • complication rates

    during procedure

Study Arms (2)

ultrasound

OTHER

Caudal bloc guided by Ultrasound

Procedure: Ultrasound guided caudal Block

Conventionel

OTHER

Caudal Block based on anatomical landmarks

Procedure: Conventionel

Interventions

Ultrasound guided caudal BlockPROCEDURE

caudal block using Ultrasound

ultrasound
ConventionelPROCEDURE

Caudal Block based on anatomical landmarks

Conventionel

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bechir Hamza hospital

Tunis, Tunis Governorate, 2001, Tunisia

RECRUITING

Central Study Contacts

salma Aouadi, Hospital university assistant

CONTACT

56652210salmaaouadi1@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: caudal block based on anatomical landmarks (group C) or ultrasound-guided (group E)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the anesthesia and intensive care department

Study Record Dates

First Submitted

October 21, 2024

First Posted

October 23, 2024

Study Start

August 1, 2024

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

October 23, 2024

Record last verified: 2024-10

Locations

TU(1)