NCT01428271

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

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

Study Start

First participant enrolled

August 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

10 months

First QC Date

August 10, 2011

Last Update Submit

June 1, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • the expected site of the sacral hiatus by convential method

    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.

    approximately 5 minutes after general anesthesia

Study Arms (1)

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

Interventions

The confirmation of the real site of the sacral hiatus by ultrasonography

Herniorrhapy with caudal block

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • The history of prematurity
  • he histories of the infection, tumor, and operation in sacrum 3. The history or suspicion of meningomyelocele

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

  • Senoglu N, Senoglu M, Oksuz H, Gumusalan Y, Yuksel KZ, Zencirci B, Ezberci M, Kizilkanat E. Landmarks of the sacral hiatus for caudal epidural block: an anatomical study. Br J Anaesth. 2005 Nov;95(5):692-5. doi: 10.1093/bja/aei236. Epub 2005 Sep 9.

    PMID: 16155035BACKGROUND

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2011

First Posted

September 2, 2011

Study Start

August 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations