UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013121 |
|---|---|
| Receipt number | R000015305 |
| Scientific Title | The effect of alkalization of lacal anesthetic for subclacicular brachial plexus block |
| Date of disclosure of the study information | 2014/02/10 |
| Last modified on | 2017/08/14 21:27:56 |
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Basic information
Public title
The effect of alkalization of lacal anesthetic for subclacicular brachial plexus block
Acronym
The effect of alkalization of lacal anesthetic for subclacicular brachial plexus block
Scientific Title
The effect of alkalization of lacal anesthetic for subclacicular brachial plexus block
Scientific Title:Acronym
The effect of alkalization of lacal anesthetic for subclacicular brachial plexus block
Region
| Japan |
Condition
Condition
renal falure
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of alkalization of lacal anesthetic for subclacicular brachial plexus block
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
onset and dulation time
VAS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1% mepivacaine 20ml one shoot
Interventions/Control_2
alkalization of 1% mepivacaine 20ml (1% mepivacaine 19.5ml + 8.4% sodium bicarbonate 0.5ml) one shoot
Interventions/Control_3
0.375% ropivacaine 20ml one shoot
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who need vascular access surgery
Key exclusion criteria
Subjects who, in the investigator's opinion, might not be suitable for the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kayo Tsugita |
Organization
University of Fukui Hospital
Division name
Anesthesiology and Reanimatology
Zip code
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193 Japan
TEL
0776-61-8391
ktsugita@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kayo Tsugita |
Organization
University of Fukui Hospital
Division name
Anesthesiology and Reanimatology
Zip code
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193 Japan
TEL
0776-61-8391
Homepage URL
ktsugita@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui Hospital, Department of Anesthesiology and Reanimatology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 02 | Month | 10 | 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
| 2012 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | 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 | 02 | Month | 10 | Day |
Last modified on
| 2017 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015305
