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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019149
Receipt No. R000022141
Scientific Title Examination of the expanse of the local anesthetic with quadratus lumborum block.
Date of disclosure of the study information 2015/10/31
Last modified on 2016/02/02

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Basic information
Public title Examination of the expanse of the local anesthetic with quadratus lumborum block.
Acronym Examination of the expanse of the local anesthetic with quadratus lumborum block.
Scientific Title Examination of the expanse of the local anesthetic with quadratus lumborum block.
Scientific Title:Acronym Examination of the expanse of the local anesthetic with quadratus lumborum block.
Region
Japan

Condition
Condition Normal adult
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 .The frequency that local anesthetic arrives at the paravertebral space.
Basic objectives2 Others
Basic objectives -Others We confirm the range of the expanse.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We confirm the expanse of the local anesthetic by MRI after 30 minutes.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 posterior TAP with 0.2% ropivacaine 20ml, the other side, quadratus lumborum block with 0.2 % ropivacaine 20ml. After 30 minutes, MRI will be done.
After more two days, crossover test.
5 persons, and 10 cases will be done.
Interventions/Control_2
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 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Tamura
Organization Japanese Red Cross Nagoya Daiichi Hospital
Division name Department of anesthesia
Zip code
Address 35, Michisita-cho 3, Nakamura-ku, Nagoya city, Aichi, Japan
TEL 052-481-5111
Email takahiro@nagoya-1st.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Tamura
Organization Japanese Red Cross Nagoya Daiichi Hospital
Division name Department of anesthesia
Zip code
Address 35, Michisita-cho 3, Nakamura-ku, Nagoya city, Aichi, Japan
TEL 052-481-5111
Homepage URL
Email takahiro@nagoya-1st.jrc.or.jp

Sponsor
Institute Nagoya university graduste school of medicine
Institute
Department

Funding Source
Organization Nagoya university graduste 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
2015 Year 10 Month 31 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
2015 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 01 Day
Last follow-up date
2016 Year 02 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 09 Month 29 Day
Last modified on
2016 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022141

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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