UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007541 |
|---|---|
| Receipt number | 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 11:33:35 |
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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
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
ssakura@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University, Faculty of Medicine, University 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008593
