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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 24, 2019
First Posted Date July 31, 2019
Last Update Posted Date June 16, 2020
Actual Study Start Date July 24, 2019
Actual Primary Completion Date March 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 29, 2019)
Required volume of local anesthetics [ Time Frame: 1 day ]
Required volume of local anesthetics to reach each level
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Estimation of Injection Volume for Caudal Epidural Block Using Dynamic US Imaging in Children
Official Title Estimation of Injection Volume for Caudal Epidural Block Using Dynamic Ultrasound Imaging in Young Pediatric Patients: an Observational Study
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Caudal Epidural Block
Intervention Procedure: ultrasound guided caudal epidural block
dynamic ultrasound imaging of the spread of local anesthetics
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 29, 2019)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date March 14, 2020
Actual Primary Completion Date March 13, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months to 24 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT04039295
Other Study ID Numbers 2019-0750
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Hajung Kim, Asan Medical Center
Study Sponsor Asan Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Hyungtae Kim, MD, PhD Asan Medical Center
PRS Account Asan Medical Center
Verification Date June 2020