UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034989 |
|---|---|
| Receipt number | 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 | 2019/11/24 16:39:52 |
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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
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
yo-ma@anes.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
32
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
Completed
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 | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039894
