UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007186 |
|---|---|
| Receipt number | R000008419 |
| Scientific Title | Comparison between ultrasound-guided technique and subcutaneous infiltration technique on the intercostobrachial nerve block |
| Date of disclosure of the study information | 2012/02/05 |
| Last modified on | 2016/06/10 11:33:03 |
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Basic information
Public title
Comparison between ultrasound-guided technique and subcutaneous infiltration technique on the intercostobrachial nerve block
Acronym
Ultrasound-guided intercostobrachial nerve block
Scientific Title
Comparison between ultrasound-guided technique and subcutaneous infiltration technique on the intercostobrachial nerve block
Scientific Title:Acronym
Ultrasound-guided intercostobrachial nerve block
Region
| Japan |
Condition
Condition
diseases that require surgery in the elbow, forearm and/or hand
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of intercostobrachial nerve block between ultrasound-guided technique and subcutaneous infiltration technique
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The success rate of intercostobrachial nerve block
Key secondary outcomes
Incidence of complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Ultrasound-guided technique
Interventions/Control_2
Subcutaneous infiltration technique
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing surgery in the elbow, forearm and/or hand.
Key exclusion criteria
Patients with a history of diabetes mellitus, neurologic disease, or injections at the site of injection
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaoru Hara |
Organization
Matsue Seikyo Hospital
Division name
Department of Anesthesia
Zip code
Address
8-8-8, Nishi-tsuda, Matsue City, Shimane
TEL
0852-23-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaoru Hara |
Organization
Matsue Seikyo Hospital
Division name
Department of Anesthesia
Zip code
Address
8-8-8, Nishi-tsuda, Matsue City, Shimane
TEL
0852-23-1111
Homepage URL
khara531@hotmail.com
Sponsor or person
Institute
Matsue Seikyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Shimane University, Faculty of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
松江生協病院（島根県）
島根大学医学部附属病院（島根県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 05 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
| 2012 | Year | 02 | Month | 01 | Day |
Last modified on
| 2016 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008419
