Estimation of Injection Volume for Caudal Epidural Block Using Dynamic US Imaging in Children

June 15, 2020 updated by: Hajung Kim, Asan Medical Center

Estimation of Injection Volume for Caudal Epidural Block Using Dynamic Ultrasound Imaging in Young Pediatric Patients: an Observational Study

Caudal epidural block is the most commonly used technique for analgesia in pediatric patients. Although there are clinically used doses of local anesthetics for caudal epidural block, we do not know exactly how much levels are blocked in young children. Thus, we aimed to identify the spreading of injection of local anesthetics for caudal epidural block using ultrasound imaging in young children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

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

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Among the patients who are scheduled to undergo elective polydactyly / syndactyly / polysyndactyly correction surgery in Asan Medical Center, the patients who meet the inclusion criteria are included.

Description

Inclusion Criteria:

  • age: 6-24months
  • ASA 1-3
  • body weight: 5-20kg

Exclusion Criteria:

  • patients who refuse to participate
  • local site infection, pilonidal cyst, spina bifida
  • spinal/meningeal abnormality
  • patients who discharge after surgery without admission
  • patients who is judged ineligible for other reasons by the authors

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Required volume of local anesthetics
Time Frame: 1 day
Required volume of local anesthetics to reach each level
1 day

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Hyungtae Kim, MD, PhD, Asan Medical Center

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)

July 24, 2019

Primary Completion (Actual)

March 13, 2020

Study Completion (Actual)

March 14, 2020

Study Registration Dates

First Submitted

July 24, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 15, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-0750

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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