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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012743
Receipt No. R000014858
Scientific Title The diffusional pathway and pharmacokinetics of local anesthetics following new approach (costo-vertebral canal block) of thoracic paravertebral nerve block
Date of disclosure of the study information 2014/01/01
Last modified on 2014/01/01

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Basic information
Public title The diffusional pathway and pharmacokinetics of local anesthetics following new approach (costo-vertebral canal block) of thoracic paravertebral nerve block
Acronym The reseach for new approach technique of thoracic paravertebral nerve block
Scientific Title The diffusional pathway and pharmacokinetics of local anesthetics following new approach (costo-vertebral canal block) of thoracic paravertebral nerve block
Scientific Title:Acronym The reseach for new approach technique of thoracic paravertebral nerve block
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery Anesthesiology Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A new approach for throcic paravertebral block has been reported and we provisionally-designated as costvertebral canal block(CVC block). This technique make the local anesthetics injection on lamina and expected less serious complications than clasical technique.However, the local anesthetics pathway to nerves were poorly understood. In this study, we evaluate spreading manner of localanesthetics following CVC block using contrast dye.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Local anesthetics pathway through the muscular compartment with evaluating X-lay or US image.
Key secondary outcomes analgesic efficacy and pharmacokinetics of serum local anesthetics following CVC block.

Base
Study type

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 CVC block using local anesthetc soltion containing contrast dye
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
70 years-old >=
Gender Male and Female
Key inclusion criteria ASA physical status 1or 2
Key exclusion criteria patients who have past history of allergic reaction for contrast dye or local anesthetics
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Kitayama
Organization Hirosaki University Medicine Hospital
Division name Department of Anesthesiology
Zip code
Address Zaifucho5, Hirosaki 036-8563
TEL +81-0172-39-5111
Email kitasan@cc.hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masato Kitayama
Organization Hirosaki University Medicine Hospital
Division name Department of Anesthesiology
Zip code
Address Zaifucho5, Hirosaki 036-8563
TEL +81-0172-39-5111
Homepage URL
Email kitasan@cc.hirosaki-u.ac.jp

Sponsor
Institute Department of anesthesiology, Tsugaru Seihokugo kouiki Union, Seihoku central Hospital
Institute
Department

Funding Source
Organization Department of Anesthesiology, Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of anesthesiology, Tsugaru Seihokugo kouiki Union, Seihoku central Hospital
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 つがる西北五広域連合西北中央病院

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 01 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 Preinitiation
Date of protocol fixation
2013 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 06 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
2014 Year 01 Month 01 Day
Last modified on
2014 Year 01 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014858

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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