UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038581
Receipt number R000043965
Scientific Title optimal local anesthetic concentration for ultrasound guided rectus sheath block in pediatric patients
Date of disclosure of the study information 2019/11/15
Last modified on 2019/11/14 12:47:01

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Basic information

Public title

optimal local anesthetic concentration for ultrasound guided rectus sheath block in pediatric patients

Acronym

optimal local anesthetic concentration for ultrasound guided rectus sheath block in pediatric patients

Scientific Title

optimal local anesthetic concentration for ultrasound guided rectus sheath block in pediatric patients

Scientific Title:Acronym

optimal local anesthetic concentration for ultrasound guided rectus sheath block in pediatric patients

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 dose of ropivacaine for ultrasound guided rectus sheath block in children anesthetized with 2% sevoflurane.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Analgesic effect at skin incision

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

1 years-old <=

Age-upper limit

12 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 Shinichi
Middle name
Last name Inomata

Organization

Institute of Clinical Medicine
University of Tsukuba

Division name

Department of Anesthesiology

Zip code

305-8576

Address

Tennodai 1-1-1 Tsukuba-city, Ibaraki, JAPAN

TEL

029-853-3092

Email

inomatas@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name Shinichi
Middle name
Last name Inomata

Organization

Institute of Clinical Medicine University of Tsukuba

Division name

Department of anesthesiology

Zip code

305-8576

Address

Tennodai 1-1-1 Tsukuba-city, Ibaraki, JAPAN

TEL

029-853-3092

Homepage URL


Email

inomatas@md.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

University of Tsukuba

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

Tsukuba clinical reserch and developent organization

Address

Amakubo 2-1-1, Tsukuba, Ibaraki, JAPAN

Tel

029-853-3914

Email

t-credo.adm@un.tsukuba.ac.jp


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

2019 Year 11 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

22

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

No longer recruiting

Date of protocol fixation

2012 Year 04 Month 01 Day

Date of IRB

2012 Year 09 Month 21 Day

Anticipated trial start date

2016 Year 11 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Obsavation of analgesic effect of rectus sheath block at skin incision


Management information

Registered date

2019 Year 11 Month 14 Day

Last modified on

2019 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043965


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name