UMIN-CTR Clinical Trial

Public title

Ultrasound Echogram Oriented Anatomical Measurement for Caudal Epidural Anesthesia in Pediatric Patients

Acronym

Ultrasound Echogram Oriented Anatomical Measurement for Caudal Anesthesia in Pediatric Patients

Scientific Title

Ultrasound Echogram Oriented Anatomical Measurement for Caudal Epidural Anesthesia in Pediatric Patients

Scientific Title:Acronym

Ultrasound Echogram Oriented Anatomical Measurement for Caudal Anesthesia in Pediatric Patients

Region

Japan

Condition

scrotal hernia,scrotocele,
phimosis,umbilical hernia,
urethral stenosis,rectal-skin fistula
High anal atresia,hypospadia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Caudal block is easily performed because the landmarks are superficial. However, the pediatric sacral hiatus is small in size and shallow in depth. Under general anesthesia, we evaluated whether the distance from the two superolateral sacral crests increased with growth; whether the triangle, formed between the apex of the sacral hiatus and the superolateral sacral crests, was equilateral; and whether the expansion of the epidural area could be confirmed by ultrasound echogram.

Basic objectives2

Others

Basic objectives -Others

We evaluate whether the triangle, formed between the apex of the sacral hiatus and the superolateral sacral crests, was equilateral; and whether the expansion of the epidural area could be confirmed by ultrasound echogram.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

The distance from the two superolateral sacral crests

Key secondary outcomes

Whether the triangle, formed between the apex of the sacral hiatus and the superolateral sacral crests
Whether the expansion of the epidural area could be confirmed by ultrasound echogram.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Maneuver

Interventions/Control_1

whether an equilateral triangle was formed between the apex of the sacral hiatus and the bilateral superolateral sacral crests

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

0

years-old

<=

Age-upper limit

10

years-old

>=

Gender

Male and Female

Key inclusion criteria

Under general anesthesia, the pediatric patients receive the caudal anesthesia

Key exclusion criteria

spina bifida

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	Makoto Ozaki

Organization

Tokyo Women's Medical University Hospital

Division name

Department of Anesthesia

Zip code

Address

8-1 Kawada-chou Shinjyuku-ku Tokyo Japan

TEL

0333538111

Email

yukako1@rg8.so-net.ne.jp

Name of contact person

1st name
Middle name
Last name	Yukako Abukawa

Organization

Tokyo Women's Medical University Hospital

Division name

Department of Anesthesia

Zip code

Address

8-1 Kawada-chou Shinjyuku-ku Tokyo Japan

TEL

03-3353-8111

Homepage URL

Email

yukako1@rg8.so-net.ne.jp

Institute

Tokyo Women's Medical University

Institute

Department

Personal name

Organization

Tokyo Women's Medical University
Department of Anesthesia

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

06

Month

14

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Two patients were excluded because the superolateral sacral crests and sacral hiatus could not be palpated. The base of the triangle increased in proportion to age up to 10 years old, with a significant correlation between age and the length of the base. The triangle was not an equilateral triangle under 7 years old. The sacral hiatus could be identified by ultrasound and we could confirm expansion of the epidural space in all patients.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2008

Year

12

Month

01

Day

Date of IRB

Anticipated trial start date

2009

Year

01

Month

05

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

06

Month

14

Day

Last modified on

2016

Year

01

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019062