Ultrasound Guided Investigation Of The Anatomical Features For Caudal Block In Children With Sacral Dimple

February 23, 2023 updated by: Celal Kaya, Istanbul University
When dimples are detected in the sacral region, most practitioners consider it to be a sign of spinal anomaly and avoid caudal block. Ultrasound guided investigation of the anatomical features for caudal block in normal children and in children with sacral dimple will be informative for practitioners.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A dimple over the sacrum may be an isolated finding or a sign of underlying spinal abnormality. Therefore, most practitioners are confused to perform a caudal block. Ultrasonography is a safe and cost effective screening tool in pediatric patients. Ultrasound guided investigation of the anatomical features of sacral region may play a key role to eliminate suspicions. It is possible to detect spinal abnormalities and also measuring dural sac level, distance between dural sac and estimated needle insertion site or needle entry angle. In this study, we will examine whether there is a difference between normal children and children with dimple in the sacral region.

Study Type

Interventional

Enrollment (Actual)

120

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 Locations

  • Turkey
      • Istanbul, Turkey, 34000
        • Istanbul University Cerrahpasa

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

1 month to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Children aged 1-72 months who are taken to the operating room for any reason

Exclusion Criteria: Patients with

  • spinal anomalies,
  • history of prematurity,
  • neurological disorder
  • syndromic illness.

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: ultrasound evaluation of sacral region in normal pediatric patients

Ultrasound evaluation of sacral region will be performed to detect spinal abnormality.

Dural sac level and its distance to estmated injection site, optimal entry angle for caudal block will be measured.
Device: ultrasound evaluation
ultrasound evaluation of normal patients and patients who have a sacral dimple
Active Comparator: ultrasound evaluation of sacral region in patients with sacral dimple

Ultrasound evaluation of sacral region will be performed to detect spinal abnormality.

Dural sac level and its distance to estmated injection site, optimal entry angle for caudal block will be measured.
Device: ultrasound evaluation
ultrasound evaluation of normal patients and patients who have a sacral dimple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ultrasound measurement-1
Time Frame: 1 min
Dural sac level (mm)
1 min
ultrasound measurement-2
Time Frame: 1 min
distance between injection site and dural sac(mm)
1 min
ultrasound measurement-3
Time Frame: 1 min
optimal entry angle (0-angle degree) for caudal block
1 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ultrasound evaluation of sacral region
Time Frame: 10 minutes
searching for spinal abnormalites in patients with sacral dimple
10 minutes

Collaborators and Investigators

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

Sponsor

Istanbul University

Investigators

  • Study Director: Guner Kaya, Prof., Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 11, 2022

Primary Completion (Actual)

February 11, 2023

Study Completion (Actual)

February 11, 2023

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

April 24, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 72109855-604.01.01-231115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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