UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002587 |
|---|---|
| Receipt number | 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 13:13:39 |
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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
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
bluesapphire1226@gmail.com
Sponsor or person
Institute
Department of anesthesiology, Kitasato Institute Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003093
