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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025014
Receipt No. R000028786
Scientific Title A resarch of Local Anesthesia spreading area and anesthetic area by quadratus lumborm block.
Date of disclosure of the study information 2017/01/15
Last modified on 2017/08/04

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Basic information
Public title A resarch of Local Anesthesia spreading area and anesthetic area by quadratus lumborm block.
Acronym A resarch of Local Anesthesia spreading area and anesthetic area by quadratus lumborm block.
Scientific Title A resarch of Local Anesthesia spreading area and anesthetic area by quadratus lumborm block.
Scientific Title:Acronym A resarch of Local Anesthesia spreading area and anesthetic area by quadratus lumborm block.
Region
Japan

Condition
Condition Adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Local anesthesia spreading area
Basic objectives2 Others
Basic objectives -Others Anesthetic area
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We confirm the expanse of the local anesthetic by MRI.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Quadratus lumborm block with 0.2% ropivacaine 20ml.
After 60 minutes, MRI will be done.
After 90 minutes, anethetized area was checked by cold sign and/or pin prick test.
After more two days, crossover test.
5 persons, and 10 cases will be done.
Interventions/Control_2 the other side, quadratus lumborum block, which the injection point is changed, with 0.2 % ropivacaine 20ml.
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
65 years-old >=
Gender Male and Female
Key inclusion criteria The volunteer that informed consent was provided.
Key exclusion criteria Anatominal transformation of the chest-lumbar vertebrae
Operation career of the chest lumbar vaertebrae
Operation career of the associated body surface
Caustrophobia
The internal metal not to fit MRI
Within two weeks before at least examination, it is a person with the internal use of NSAIDs
Coaglopathy
Electrocardiogram abnormality
Allergy for the drug to use for this examination
When we judge the participation in this examination to be inappropriate
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Tamura
Organization Nagoya University Graduate school of medicine
Division name Department of Anesthesiology
Zip code
Address Tsurumai-cho 65, Showa-ku, Nagoya, 466-8560, Japan
TEL 052-741-2111
Email takahiro@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Tamura
Organization Nagoya University Graduate school of medicine
Division name Department of Anesthesiology
Zip code
Address Tsurumai-cho 65, Showa-ku, Nagoya, 466-8560, Japan
TEL 052-741-2111
Homepage URL
Email takahiro@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 15 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 Completed
Date of protocol fixation
2016 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 28 Day
Last modified on
2017 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028786

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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