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The Caudal Space in Children: Ultrasound Evaluation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01896076
First received: June 30, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Hydrocele
Inguinal Hernia
Hypospadia
Cryptorchidism
Genitourinary Disease
Other: ultrasound evaluation of caudal space

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • ultrasound evaluation of caudal space [ Time Frame: Right after induction of general anesthesia, the patients were placed in the lateral position. The ultrasound evaluation include transverse and longitudinal view. ] [ Designated as safety issue: No ]

    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.



Enrollment: 300
Study Start Date: June 2013
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pediatric patients in urologic surgery
Pediatric patients undergoing caudal block for urologic surgery were included in this study.
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.


  Eligibility

Ages Eligible for Study:   up to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients aged 0 - 84 months who were scheduled to undergo elective urological surgery. This investigation was conducted at a single tertiary medical center (Severance Hospital), Seoul, Republic of Korea.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896076

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01896076     History of Changes
Other Study ID Numbers: 4-2013-0244
Study First Received: June 30, 2013
Last Updated: July 24, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
caudal space
children
ultrasound evaluation

Additional relevant MeSH terms:
Cryptorchidism
Hernia, Inguinal
Hypospadias
Urologic Diseases
Congenital Abnormalities
Endocrine System Diseases
Genital Diseases, Male
Gonadal Disorders
Hernia
Hernia, Abdominal
Pathological Conditions, Anatomical
Penile Diseases
Testicular Diseases
Urogenital Abnormalities

ClinicalTrials.gov processed this record on November 25, 2014