Ultrasonographic Evaluation of Drug Spread in Epidural Space During Caudal Block in Children

March 4, 2013 updated by: Yonsei University

Caudal block is the world-widely used technique for an effective postoperative analgesia in children undergoing OPD-based infra-umbilical surgery. Because the caudal block is usually performed with a single-shot, proper dosage is required to achieve sufficient analgesic levels. Several clinical researches have been performed to assess the drug spread levels using mathematical equation, X-ray evaluation, and ultrasonography during caudal block in children. In our previous study using fluoroscopy, we obtained the results that the established weight-based doses provided adequate block levels for each type of surgery.

Ultrasonography is precise tool to evaluate the spinal structures and can provide estimated information in real time during caudal or epidural block in children.

The aim of this study is to evaluate the drug spread level with a weight-based doses using ultrasonography during caudal block in children and assess the reliability of the real time ultrasonography to determine the drug spread levels. After general anesthesia, the patient will be placed in lateral decubitus position for caudal block. Total 1.5 ml/kg of 0.15% ropivacaine will be injected into the caudal space. The spread level will be step-wise evaluated using ultrasonography at the injected drug dose of 0.5 ml/kg, 1.0 ml/kg, 1.25 ml/kg, and 1.5 ml/kg.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

72

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

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

3 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

3 months old ~ 5 years old children undergoing minor infra-umbilical urological surgery

Description

Inclusion Criteria:

  • children who needed caudal block for postoperative analgesia (age 3 months ~ 5 years old)
  • Consent from one of parents 3. ASA physical status I or II

Exclusion Criteria:

  • bleeding tendency
  • spinal anomaly
  • infection focus on back
  • allergic reaction to local anesthetics
  • foreigner of illiteracy who cannot read consent form

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 1
4 times evaluation according to doses in 1 group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
drug spread level with a weight-based doses
Time Frame: every 10 seconds for 1 minute during drug injection (10, 20, 30, 40, 50, and 60 seconds).
  1. spread levels of drug within the epidural space during drug injection with caudal block at every doses using real-time ultrasound examination.
  2. maximum spread levels within the epidural space
every 10 seconds for 1 minute during drug injection (10, 20, 30, 40, 50, and 60 seconds).

Collaborators and Investigators

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

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Hae Kum Kil, MD, MS, Severance Hospital

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

March 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

April 5, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 22, 2011

Study Record Updates

Last Update Posted (Estimate)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4-2010-0775

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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