UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison between in plane and out of plane approaches for continuous interscalene brachial plexus block
Title of the study (Brief title)	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

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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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shinichi Sakura
Organization	Shimane University, Faculty of Medicine, University hospital
Division name	Surgical Center
Address	89-1 Enya-cho, Izumo City, Shimane
TEL	0853-20-2295
Email

Public contact
Name of contact person	Shinichi Sakura
Organization	Shimane University, Faculty of Medicine, University hospital
Division name	Surgical Center
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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