UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012907
Receipt number R000015090
Scientific Title optimal local anesthetic concentration for ultrasound guided ilioinguinal iliohypogastric nerve block in pediatric patients anesthetized with 2% sevoflurane
Date of disclosure of the study information 2014/01/21
Last modified on 2014/01/21 11:12:41

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Basic information

Public title

optimal local anesthetic concentration for ultrasound guided ilioinguinal
iliohypogastric nerve block in pediatric patients anesthetized with 2% sevoflurane

Acronym

optimal local anesthetic concentration for ultrasound guided ilioinguinal
iliohypogastric nerve block in pediatric patients anesthetized with 2% sevoflurane

Scientific Title

optimal local anesthetic concentration for ultrasound guided ilioinguinal
iliohypogastric nerve block in pediatric patients anesthetized with 2% sevoflurane

Scientific Title:Acronym

optimal local anesthetic concentration for ultrasound guided ilioinguinal
iliohypogastric nerve block in pediatric patients anesthetized with 2% sevoflurane

Region

Japan


Condition

Condition

inguinal hernia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to determine the 50% effective (minimum) and the 95% effective (optimum) local analgesic concentration of ropivacaine for ultrasound guided INB in children anesthetized with 2% sevoflurane.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Observational

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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



Eligibility

Age-lower limit

0 years-old <=

Age-upper limit

11 years-old >=

Gender

Male and Female

Key inclusion criteria

children scheduled for elective unilateral inguinal hernia repair under general anaesthesia

Key exclusion criteria

allergy to local anesthetics of the amide type, parental refusal.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi inomata

Organization

Department of Anesthesiology,
Institute of Clinical Medicine,
Graduate School of Comprehensive Human Sciences

Division name

Department of Anesthesiology

Zip code


Address

Tsukuba City, Ibaraki 305-8575, Japan

TEL

+81-29-853-3092

Email

inomatas@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichi inomata

Organization

university of tsukuba

Division name

Department of Anesthesiology

Zip code


Address

Tsukuba City, Ibaraki 305-8575, Japan

TEL

+81-29-853-3092

Homepage URL


Email

inomatas@md.tsukuba.ac.jp


Sponsor or person

Institute

Shinichi inomata

Institute

Department

Personal name



Funding Source

Organization

university of tsukuba hospita

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 21 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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



Progress

Recruitment status

Completed

Date of protocol fixation

2007 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2007 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

random sample


Management information

Registered date

2014 Year 01 Month 21 Day

Last modified on

2014 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015090


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name