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

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ClinicalTrials.gov Identifier: NCT04039295
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Hajung Kim, Asan Medical Center

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.

Condition or disease Intervention/treatment
Caudal Epidural Block Procedure: ultrasound guided caudal epidural block

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Estimation of Injection Volume for Caudal Epidural Block Using Dynamic Ultrasound Imaging in Young Pediatric Patients: an Observational Study
Actual Study Start Date : July 24, 2019
Actual Primary Completion Date : March 13, 2020
Actual Study Completion Date : March 14, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: ultrasound guided caudal epidural block
    dynamic ultrasound imaging of the spread of local anesthetics


Primary Outcome Measures :
  1. Required volume of local anesthetics [ Time Frame: 1 day ]
    Required volume of local anesthetics to reach each level



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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039295


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Hyungtae Kim, MD, PhD Asan Medical Center
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Responsible Party: Hajung Kim, Clinical instructor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT04039295    
Other Study ID Numbers: 2019-0750
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No