Estimation of Injection Volume for Caudal Epidural Block... | NCT04039295

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

NCT04039295

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Jun 16, 2020Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Caudal Epidural Block

Interventions

ultrasound guided caudal epidural block

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2019Actual

Primary Completion Date

Mar 13, 2020Actual

Completion Date

Mar 14, 2020Actual

First Submitted Date

Jul 24, 2019

First Submission Date that Met QC Criteria

Jul 29, 2019

First Posted Date

Jul 31, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2020

Last Update Posted Date

Jun 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound guided caudal epidural block	Procedure	dynamic ultrasound imaging of the spread of local anesthetics

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

24 Months

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hyungtae Kim, MD, PhD	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul		05505	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37429622	Derived	Kim HJ, Kim H, Lee S, Koh WU, Park SS, Ro Y. Reconsidering injection volume for caudal epidural block in young pediatric patients: a dynamic flow tracking experimental study. Reg Anesth Pain Med. 2024 May 7;49(5):355-360. doi: 10.1136/rapm-2023-104409.