NCT01896076

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 28, 2014

Status Verified

July 1, 2014

Enrollment Period

8 months

First QC Date

June 30, 2013

Last Update Submit

July 24, 2014

Conditions

Keywords

caudal spacechildrenultrasound evaluation

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Pediatric patients in urologic surgery

Pediatric patients undergoing caudal block for urologic surgery were included in this study.

Other: ultrasound evaluation of caudal space

Interventions

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.

Pediatric patients in urologic surgery

Eligibility Criteria

AgeUp to 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Patients with any contraindication to caudal epidural block were excluded.
  • coagulopathy
  • allergy to local anesthetics
  • infection at the puncture site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Testicular HydroceleHernia, InguinalHypospadiasCryptorchidismUrogenital Diseases

Condition Hierarchy (Ancestors)

Testicular DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesGonadal DisordersEndocrine System DiseasesHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsPenile DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2013

First Posted

July 11, 2013

Study Start

June 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

July 28, 2014

Record last verified: 2014-07

Locations