UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012743 |
|---|---|
| Receipt number | 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 17:17:33 |
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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
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
kitasan@cc.hirosaki-u.ac.jp
Sponsor or person
Institute
Department of anesthesiology, Tsugaru Seihokugo kouiki Union, Seihoku central Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014858
