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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002587
Receipt No. R000003093
Scientific Title Comparison of two different anesthetic techniques for femur neck fracture
Date of disclosure of the study information 2009/10/06
Last modified on 2012/04/06

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Basic information
Public title Comparison of two different anesthetic techniques for femur neck fracture
Acronym Nerve block for FNF
Scientific Title Comparison of two different anesthetic techniques for femur neck fracture
Scientific Title:Acronym Nerve block for FNF
Region
Japan

Condition
Condition Femur Neck fracture
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Spinal anesthesia is often selected for Femur neck fracture (FNF) operation. However, elderly people often develop FNF, therefore, it is often hard to enforce spinal anesthesia, and it's side effects will occur compared with young people. We examine peripheral nerve blocks improve perioperative managements.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual analogue scale
Key secondary outcomes intraoperative hypotension

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 spinal block
Interventions/Control_2 peripheral nerve block
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
100 years-old >
Gender Male and Female
Key inclusion criteria patients undergoing surgery for femur neck fracture
Key exclusion criteria patient who cannot evaluate own pain
joint replacement
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshimune Osaka
Organization Kitasato University, Kitasato Institute Hospital
Division name Anesthegiology
Zip code
Address 5-9-1, Shirokane, MInato-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kitasato University, Kitasato Institute Hospital
Division name Anesthegiology
Zip code
Address
TEL
Homepage URL
Email bluesapphire1226@gmail.com

Sponsor
Institute Department of anesthesiology, Kitasato Institute Hospital
Institute
Department

Funding Source
Organization none
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 北里研究所病院(東京都)

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 06 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 Terminated
Date of protocol fixation
2009 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2011 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 06 Day
Last modified on
2012 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003093

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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