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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007186
Receipt No. 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

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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
Email

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
Email khara531@hotmail.com

Sponsor
Institute Matsue Seikyo Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008419

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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