UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019149 |
|---|---|
| Receipt number | 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 10:17:02 |
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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
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
takahiro@nagoya-1st.jrc.or.jp
Sponsor or person
Institute
Nagoya university graduste school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022141
