UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Articular branches of the femoral nerve block; it`s analgesic efficacy on patients with proximal femoral fracture
Title of the study (Brief title)	Articular branches of the femoral nerve block; it`s analgesic efficacy on patients with proximal femoral fracture
Region	Japan

Condition
Condition	proximal femoral fractures
Classification by specialty	Orthopedics Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Proximal femoral fractures are more common in elderly people. Severe pain may lead to delirium and delay the recovery. Therefore, The purpose of this study was to assess the effectiveness of femoral nerve of articular branch.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual analog scale Time to first analgesic drug use
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Femoral nerve of articular branch block
Interventions/Control_2	None
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients whose American Society of Anesthesiologists Physical Status are 1-3, planned to Short-femoral-nail insertion and agree to Femoral nerve of articular branch block for postoperative analgesia are enrolled in this study.
Key exclusion criteria	Exclude criteria are the patients who have local anesthetic allergy or contrast agent allergy or peripheral neuropathy or coagulation abnormality.
Target sample size	20

Research contact person
Name of lead principal investigator	Takahiro Sugiura
Organization	National hospital organization Tokyo Medical Center
Division name	Anesthesiology
Address	2-5-1, Higashigaoka Meguro-ku Tokyo 152-8902
TEL	03-3411-0111
Email	sugiura.takahiro@navy.plala.or.jp

Public contact
Name of contact person	Takahiro Sugiura
Organization	National hospital organization Tokyo Medical Center
Division name	Anesthesiology
Address	2-5-1, Higashigaoka Meguro-ku Tokyo 152-8902
TEL	03-3411-0111
Homepage URL
Email	sugiura.takahiro@navy.plala.or.jp

Sponsor
Institute	National hospital organization Tokyo Medical Center
Institute
Department

Funding Source
Organization	None
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	2014 Year 12 Month 22 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 12 Month 10 Day
Anticipated trial start date	2014 Year 12 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 20 Day
Last modified on	2017 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018572