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OpenTrials
Completed

NCT Number: NCT04861935

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

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.

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Key information

Conditions

Sacrococcygeal Disorder

Age range

1 month–72 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Cerrahpasa

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

ultrasound evaluation

Device

ultrasound evaluation of normal patients and patients who have a sacral dimple

Primary outcomes

  1. ultrasound measurement-1

    Time frame: 1 min

    Dural sac level (mm)

  2. ultrasound measurement-2

    Time frame: 1 min

    distance between injection site and dural sac(mm)

  3. ultrasound measurement-3

    Time frame: 1 min

    optimal entry angle (0-angle degree) for caudal block

Secondary outcomes

  1. ultrasound evaluation of sacral region

    Time frame: 10 minutes

    searching for spinal abnormalites in patients with sacral dimple

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2021
Registry last updated
Feb 24, 2023

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.

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