UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005230 |
|---|---|
| Receipt number | R000006219 |
| Scientific Title | The examination of the effect of the peripheral nerve continuance block under the supersonic wave guide |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2011/03/10 10:13:50 |
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Basic information
Public title
The examination of the effect of the peripheral nerve continuance block under the supersonic wave guide
Acronym
The examination of the effect of the peripheral nerve continuance block under the supersonic wave guide
Scientific Title
The examination of the effect of the peripheral nerve continuance block under the supersonic wave guide
Scientific Title:Acronym
The examination of the effect of the peripheral nerve continuance block under the supersonic wave guide
Region
| Japan |
Condition
Condition
Whether there is an equal analgesic effect in a peripheral nerve block with supersonic wave guide and epidural block
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Whether there is an equal analgesic effect in a peripheral nerve block with supersonic wave guide and epidural block
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Whether there is an equal analgesic effect in a peripheral nerve block with supersonic wave guide and epidural block
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Femoral nerve block in an inguinal region
Interventions/Control_2
epidural anesthesia
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
More than 20 years oldpatient.An agreement is able to provided in a document.
Key exclusion criteria
A patient with a cervertebrae disease, a blood coagulation disease, an autoimmune disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Munehiro Masuzawa |
Organization
Kansai medical university
Division name
Department of anesthesiology
Zip code
Address
2-3-1 Shinmachi Hirakata OSAKA
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kansai medical university
Division name
Department of anesthesiology
Zip code
Address
TEL
072-804-0101
Homepage URL
Sponsor or person
Institute
Department of anesthesiology KMU
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
none
Name of secondary funder(s)
none
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
| 2011 | Year | 04 | 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
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
| 2011 | Year | 03 | Month | 10 | Day |
Last modified on
| 2011 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006219
