Evaluation Of Caudal Epidural Anatomy By Ultrasonography İn Pediatric Patients

December 22, 2021 updated by: Celal Kaya, Istanbul University
Detailed study of ultrasonographic caudal epidural anatomy

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Caudal epidural block is one of the most common methods to provide analgesia for an infraumbilical surgery in children. Although it can be carried out safely and easily, many complications have been described so far, because of inaccurate needle injections. To perform a successful block, a good caudal epidural anatomic assessment is essential. Ultrasonography is an important tool to perform pediatric regional blocks, including caudal blocks. We believe that caudal epidural ultrasound evaluation can be an important option to decrease complications and to achieve a successful attempt; due to that we will try to describe caudal epidural ultrasound imaging and changes from one month to 84 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
348

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, 34098
        • Cerrahpasa Medical Faculty

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 7 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pediatric patients who are admitted to operating room for any pediatric surgery

Description

Inclusion Criteria:

  • Pediatric patients who applied for any pediatric surgery from 20 january to 20 july

Exclusion Criteria:

  • Premature patients
  • Patients who have any sendromic diagnosis
  • Patients who have any musculoskeletal abnormalities
  • Patients who have any spinal abnormalities

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group I
Caudal Epidural Ultrasonography will be performed in patients aged between 1-24 months
Diagnostic test: Caudal Epidural Ultrasonography
Ultrasonographic Measurement
Group II
Caudal Epidural Ultrasonography will be performed in patients aged between 25-48 months
Diagnostic test: Caudal Epidural Ultrasonography
Ultrasonographic Measurement
Group III
Caudal Epidural Ultrasonography will be performed in patients aged between 49-84 months
Diagnostic test: Caudal Epidural Ultrasonography
Ultrasonographic Measurement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Definition Of Dural Sac Termination Level By Ultrasonography
Time Frame: 5 minutes
After general anesthesia, patient will be placed in lateral decubitus position. First, a 12 MHz lineer ultrasound transducer will be placed transversely to obtain the transverse view of sacral hiatus; in this view we will try to show two sacral cornua, sacrococcygeal ligament, posterior sacral bone and caudal epidural depth. Secondly, transducer will be turned parallel to the midline or paravertebral to obtain longitudinal view; in longitudinal view we will try to obtain the images of sacral vertebral corpuses, caudal epidural area and dural sac. We will try to determine the level of dural sac termination according to a part of vertabral corpus or an intervertebral distance.
5 minutes
Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle
Time Frame: 5 minutes
Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle will be measured under longitudinal ultrasound view
5 minutes
Definition Of Average Caudal Epidural Depth By Ultrasonography
Time Frame: 5 minutes
Definition of caudal epidural depth by ultrasonography will be obtained under transverse view for every patient and average value will be defined for every age group.
5 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determination Of Sacral Cornua As An Anatomic Landmark And Confirmation By Ultrasonography
Time Frame: 5 minutes
Sacral cornua will be palpated and than will be scanned under transverse ultrasound view. Also results will be compared.
5 minutes

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ayse Cigdem Tutuncu
Kaya, Guner, M.D.
Pinar Kendigelen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Celal Kaya, MD, Istanbul 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 72109855-604.01.01-103424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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