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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034989
Receipt No. R000039894
Scientific Title A Randomized Comparative Study of the Utility of Laser-guided Probe in Ultrasound-guided Peripheral Nerve Block for the Novices.
Date of disclosure of the study information 2018/11/25
Last modified on 2019/04/16

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Basic information
Public title A Randomized Comparative Study of the Utility of Laser-guided Probe in Ultrasound-guided Peripheral Nerve Block for the Novices.
Acronym A Randomized Comparative Study of the Utility of Laser-guided Probe in Ultrasound-guided Peripheral Nerve Block for the Novices.
Scientific Title A Randomized Comparative Study of the Utility of Laser-guided Probe in Ultrasound-guided Peripheral Nerve Block for the Novices.
Scientific Title:Acronym A Randomized Comparative Study of the Utility of Laser-guided Probe in Ultrasound-guided Peripheral Nerve Block for the Novices.
Region
Japan

Condition
Condition N/A
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to verify the utility of laser-guided ultrasound probe in ultrasound-guided peripheral nerve block (USGPNB) for the novices by comparing with standard ultrasound probe using porcine phantom.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Time for successful USGPNB
Key secondary outcomes The assessment of the skill using ultrasound video
The assessment of the difficulty by the subjects

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 The use of laser-guided ultrasound probe
Interventions/Control_2 the use of standard ultrasound probe
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Medical students in Osaka University Hospital, Department of Anesthesiology
2. Junior residents in Osaka University Hospital, Department of Anesthesiology
Key exclusion criteria 1. Person who has experience of USGPNB
2. Person who refuse to participate in this study
Target sample size 32

Research contact person
Name of lead principal investigator
1st name Yoichi
Middle name
Last name Matsuda
Organization Osaka University Graduate School of Medicine
Division name Department of Anesthesiology & Intensive Care Medicine
Zip code 5650871
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL +81668793133
Email yo-ma@anes.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Yoichi
Middle name
Last name Matsuda
Organization Osaka University Graduate School of Medicine
Division name Department of Anesthesiology & Intensive Care Medicine
Zip code 5650871
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL +81668793133
Homepage URL
Email yo-ma@anes.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Pfizer Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Osaka University Hospital
Address 2-15 Yamadaoka, Suita, Osaka
Tel 06-6210-8290
Email jim-chiken@hp-crc.med.osaka-u.ac.jp

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
2018 Year 11 Month 25 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 No longer recruiting
Date of protocol fixation
2018 Year 11 Month 14 Day
Date of IRB
2018 Year 11 Month 26 Day
Anticipated trial start date
2019 Year 01 Month 08 Day
Last follow-up date
2019 Year 04 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 24 Day
Last modified on
2019 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039894

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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