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Comparison Between the Expected Site of Sacral Hiatus by Conventional Method and the Real Site by Ultrasonography for Caudal Block in Children

This study is currently recruiting participants.
Verified September 2011 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01428271
First received: August 10, 2011
Last updated: September 6, 2011
Last verified: September 2011
History of Changes
  Purpose

Caudal block is one of the most useful and popular regional block in pediatric anesthetic practice. Successful caudal block depends on the proper placement of a needle through sacral hiatus by following anatomical landmarks. The sacrum and the position of sacral hiatus are extreme variable anatomical structure. Generally, the equilateral triangle located between the apex of the sacral hiatus and posterior superior iliac spines is used in determining the location of the sacral hiatus as the conventional method. Previous study demonstrated that the triangle formed between the apex of the sacral hiatus and the posterior superior iliac spines was found to have the features of an equilateral triangle in adult. There is no study about the efficacy of the conventional method using the equilateral triangle in children. In this study, the investigators will compare between the expected site of sacral hiatus by conventional method using the equilateral triangle and the real site of the sacral hiatus confirmed by ultrasonography for caudal block in children.


Condition Intervention
Inguinal Herniorraphy
 Other: Ultrasonography

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • the expected site of the sacral hiatus by convential method [ Time Frame: approximately 5 minutes after general anesthesia ] [ Designated as safety issue: No ]
    1)The distance bewteen the midpoint of posterior superior iliac spines and the expected site of sacral hiatus by conventional method and 2)the distance between the midpoint of posterior superior iliac spines and the real site of sacral hiatus by ultrasonography.


Estimated Enrollment: 80
Study Start Date: August 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Herniorrhapy with caudal block
Children aged 0-72 months who are scheduled to undergo elective inguinal herniorrhapy under general anesthesia with caudal block
 Other: Ultrasonography
The confirmation of the real site of the sacral hiatus by ultrasonography

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children aged 0-72 months who are scheduled to undergo elective inguinal herniorraphy under general anesthesia

Criteria

Inclusion Criteria:

  • Children aged 0-72 months
  • patient whho are scheduled to undergo elective inguinal herniorraphy under general anesthesia

Exclusion Criteria:

  • The history of prematurity
  • he histories of the infection, tumor, and operation in sacrum 3. The history or suspicion of meningomyelocele
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428271

Contacts
Contact: Jeong-Rim Lee, Ph.D 82-2-2227-3840 MANYA@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Minsoo Kim     82-2-2228-6735     KMSVIOLA@yuhs.ac    
Principal Investigator: Jeong Rim Lee, Ph.D            
Sponsors and Collaborators
Yonsei University
  More Information

Publications:

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01428271     History of Changes
Other Study ID Numbers: 4-2011-0337
Study First Received: August 10, 2011
Last Updated: September 6, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on May 23, 2013