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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007541
Receipt No. R000008593
Scientific Title Comparison between in plane and out of plane approaches for continuous interscalene brachial plexus block
Date of disclosure of the study information 2012/03/21
Last modified on 2016/06/10

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Basic information
Public title Comparison between in plane and out of plane approaches for continuous interscalene brachial plexus block
Acronym Continuous interscalene brachial plexus block
Scientific Title Comparison between in plane and out of plane approaches for continuous interscalene brachial plexus block
Scientific Title:Acronym Continuous interscalene brachial plexus block
Region
Japan

Condition
Condition Diseases that require surgery in the shoulder
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the postoperative analgesic effect and the fixation and mobility of catheter between in- and out-of-plane approaches for interscalene catheter placement
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Postoperative pain scores and the degree of postoperative movement of catheter
Key secondary outcomes Postoperative complications

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 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 A catheter is inserted with an in-plane approach for ultrasound-guided continuous interscalene block
Interventions/Control_2 A catheter is inserted with an out-of plane approach for ultrasound-guided continuous interscalene block
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 arthroscopic shoulder surgery
Key exclusion criteria Patients with a history of diabetes mellitus, neurologic disease, and infections at the site of catheter insertion
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Sakura
Organization Shimane University, Faculty of Medicine, University hospital
Division name Surgical Center
Zip code
Address 89-1 Enya-cho, Izumo City, Shimane
TEL 0853-20-2295
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Sakura
Organization Shimane University, Faculty of Medicine, University hospital
Division name Surgical Center
Zip code
Address 89-1 Enya-cho, Izumo City, Shimane
TEL 0853-20-2295
Homepage URL
Email ssakura@med.shimane-u.ac.jp

Sponsor
Institute Shimane University, Faculty of Medicine, University 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 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 03 Month 21 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 21 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
2013 Year 12 Month 01 Day
Date trial data considered complete
2013 Year 12 Month 01 Day
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 21 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=R000008593

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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