UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Ultrasound evaluation of the relationship between the femoral nerve and the femoral artery at the level of the inguinal crease
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Manabu Yoshimura
Organization	Japan Community Healthcare Organization Tokuyama Central Hospital
Division name	Department of anesthesia
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	Manabu Yoshimura
Organization	Japan Community Healthcare Organization Tokuyama Central Hospital
Division name	Department of anesthesia
Address	1-1 Koda-cho, Shunan, Yamaguchi 745-8522, Japan
TEL	0834-22-4411
Homepage URL
Email	chiken2@tokuchuhp.jp

Sponsor
Institute	Tokuyama Central Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000023880