Evaluation of the Change of Penile Corpus Cavernosum After Caudal Block Using Ultrasonography in Children

February 25, 2019 updated by: Yonsei University
The purpose of this study is to evaluate the change of penile corpus cavernosum after caudal block using ultrasonography in pediatric patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

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

2 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

pediatric patients who need urologic surgery and caudal block

Description

Inclusion Criteria:

  1. Twenty (ASA status I or II) children, ages 2 to 7 yr old, who were scheduled for a urologic surgery
  2. Children who needed caudal block for postoperative analgesia

Exclusion Criteria:

  1. if there were contraindications for caudal block including hypersensitivity to any local anaesthetics, bleeding diathesis, infections at the puncture sites, or pre-existing neurological disease.
  2. patients scheduled for penile surgery

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
pediatric patients who need urologic surgery and caudal block
Other: urologic surgery and caudal block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of penile corpus cavernosum
Time Frame: 1 min after LMA insertion
Evaluation of the change of penile corpus cavernosum after caudal block using ultrasonography in children
1 min after LMA insertion
change of penile corpus cavernosum
Time Frame: 2 min after caudal block
Evaluation of the change of penile corpus cavernosum after caudal block using ultrasonography in children
2 min after caudal block
change of penile corpus cavernosum
Time Frame: 5 min after caudal block
Evaluation of the change of penile corpus cavernosum after caudal block using ultrasonography in children
5 min after caudal block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cavernosal arterial hemodynamics
Time Frame: 1 min after LMA insertion
Investigation of cavernosal arterial hemodynamics included peak systolic velocity [PS], end diastolic velocity [ED], mean velocity [MV], time-averaged maximum velocity [TAmax], time-averaged mean velocity [TAmean], pulsatility index [PI], volume flow [VF], and dorsalis pedis artery diameter [D].
1 min after LMA insertion
cavernosal arterial hemodynamics
Time Frame: 2 min after caudal block
Investigation of cavernosal arterial hemodynamics included peak systolic velocity [PS], end diastolic velocity [ED], mean velocity [MV], time-averaged maximum velocity [TAmax], time-averaged mean velocity [TAmean], pulsatility index [PI], volume flow [VF], and dorsalis pedis artery diameter [D].
2 min after caudal block
cavernosal arterial hemodynamics
Time Frame: 5 min after caudal block
Investigation of cavernosal arterial hemodynamics included peak systolic velocity [PS], end diastolic velocity [ED], mean velocity [MV], time-averaged maximum velocity [TAmax], time-averaged mean velocity [TAmean], pulsatility index [PI], volume flow [VF], and dorsalis pedis artery diameter [D].
5 min after caudal block

Collaborators and Investigators

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

Sponsor

Yonsei 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

October 2, 2015

Primary Completion (Actual)

January 22, 2016

Study Completion (Actual)

January 22, 2016

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 23, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 4-2014-0891

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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