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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01896076
Other study ID # 4-2013-0244
Secondary ID
Status Completed
Phase N/A
First received June 30, 2013
Last updated July 24, 2014
Start date June 2013
Est. completion date March 2014

Study information

Verified date July 2014
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Observational

Clinical Trial Summary

Caudal anesthesia is commonly employed in pediatrics to produce postoperative analgesia in low abdominal or urologic surgery.

An exact understanding of the anatomy of the sacral area including sacral hiatus and surrounding structures is crucial to the success of caudal block.

The aim of this study is to evaluate the anatomy of the caudal space in pediatrics by ultrasound evaluation.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date March 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 7 Years
Eligibility Inclusion Criteria:

- Patients aged 0 - 84 months who were scheduled to undergo elective urological surgery.

Exclusion Criteria:

- Patients with any contraindication to caudal epidural block were excluded.

- coagulopathy

- allergy to local anesthetics

- infection at the puncture site

Study Design

Time Perspective: Cross-Sectional


Intervention

Other:
ultrasound evaluation of caudal space
After induction of general anesthesia, the patients were placed in the lateral position. The ultrasound evaluation include transverse and longitudinal view. First, investigators place the transducer at the sacral cornua to obtain a transverse view. In the transverse view, the distance between two cornua and the depth of caudal space at the sacral hiatus were measured. In the longitudinal view, the distance from the skin to the sacrococcygeal membrane and the optimal angles and the safety distance for needle insertion depending on the points of insertions were measured. From the end of dura sac to the sacral hiatus were regarded as safety distance for the needle insertion during caudal block.

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary ultrasound evaluation of caudal space First, investigators place the transducer at the sacral cornua to obtain a transverse view.
In the transverse view, the distance between two cornua and the depth of caudal space at the sacral hiatus were measured. In the longitudinal view, the distance from the skin to the sacrococcygeal membrane and the optimal angles and the safety distance for needle insertion depending on the points of insertions were measured. From the end of dura sac to the sacral hiatus were regarded as safety distance for the needle insertion during caudal block.
Right after induction of general anesthesia, the patients were placed in the lateral position. The ultrasound evaluation include transverse and longitudinal view. No
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