UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020695
Receipt number R000023880
Scientific Title Ultrasound evaluation of the relationship between the femoral nerve and the femoral artery at the level of the inguinal crease
Date of disclosure of the study information 2016/01/22
Last modified on 2016/04/11 14:15:40

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Basic information

Public title

Ultrasound evaluation of the relationship between the femoral nerve and the femoral artery at the level of the inguinal crease

Acronym

Sonoanatomy of femoral nerve around

Scientific Title

Ultrasound evaluation of the relationship between the femoral nerve and the femoral artery at the level of the inguinal crease

Scientific Title:Acronym

Sonoanatomy of femoral nerve around

Region

Japan


Condition

Condition

patients with pelvic CT who entered the operating room regardless of their condition or disease.

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigated the relationship between the femoral nerve (FN) and femoral artery (FA) for the ultrasound guidance of the femoral nerve block (FNB) at the level of the inguinal crease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We analyze the demographic factors of the patients (age, height, and weight) and potential correlations with parameters measured using ultrasound and measure the cross sectional area of iliopsoas muscle.

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

15 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

patients with pelvic CT who entered the operating room regardless of their condition or disease.

Key exclusion criteria

patients who disagree

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Manabu Yoshimura

Organization

Japan Community Healthcare Organization Tokuyama Central Hospital

Division name

Department of anesthesia

Zip code


Address

1-1 Koda-cho, Shunan, Yamaguchi 745-8522, Japan

TEL

0834-28-4411

Email

manabu-ygc@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Manabu Yoshimura

Organization

Japan Community Healthcare Organization Tokuyama Central Hospital

Division name

Department of anesthesia

Zip code


Address

1-1 Koda-cho, Shunan, Yamaguchi 745-8522, Japan

TEL

0834-22-4411

Homepage URL


Email

chiken2@tokuchuhp.jp


Sponsor or person

Institute

Tokuyama Central Hospital

Institute

Department

Personal name



Funding Source

Organization

Tokuyama Central Hospital

Organization

Division

Category of Funding Organization

Self funding

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

2016 Year 01 Month 22 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


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

2016 Year 01 Month 22 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 22 Day

Last follow-up date

2016 Year 04 Month 01 Day

Date of closure to data entry

2016 Year 04 Month 11 Day

Date trial data considered complete

2016 Year 04 Month 11 Day

Date analysis concluded

2016 Year 04 Month 11 Day


Other

Other related information

We evaluate femoral nerve around using ultrasound


Management information

Registered date

2016 Year 01 Month 22 Day

Last modified on

2016 Year 04 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023880


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name