UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A resarch of Local Anesthesia spreading area and anesthetic area by quadratus lumborm block.
Title of the study (Brief title)	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	Takahiro Tamura
Organization	Nagoya University Graduate school of medicine
Division name	Department of Anesthesiology
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	Takahiro Tamura
Organization	Nagoya University Graduate school of medicine
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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