NCT04039295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 24, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

8 months

First QC Date

July 24, 2019

Last Update Submit

June 15, 2020

Conditions

Caudal Epidural Block

Outcome Measures

Primary Outcomes (1)

  • Required volume of local anesthetics

    Required volume of local anesthetics to reach each level

    1 day

Interventions

ultrasound guided caudal epidural blockPROCEDURE

dynamic ultrasound imaging of the spread of local anesthetics

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 37429622DERIVED

Study Officials

  • Hyungtae Kim, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical instructor

Study Record Dates

First Submitted

July 24, 2019

First Posted

July 31, 2019

Study Start

July 24, 2019

Primary Completion

March 13, 2020

Study Completion

March 14, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations

KR(1)