UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the efficacy of ultrasound-guided nerve blockade
Title of the study (Brief title)	Study on the efficacy of ultrasound-guided nerve blockade
Region	Japan

Condition
Condition	Patients undergoing surgery under nerve blocks
Classification by specialty	Surgery in general Obsterics and gynecology Dermatology Orthopedics Urology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effecacy and adverse effects of ultrasound-guided regional anesthesia using patients undergoing surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sensory and motor blockade, success rate, onset time, duration, side effects
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Each approach of the brachial plexus block
Interventions/Control_2	thoracic paravertebral block
Interventions/Control_3	Ultrasound-guided regional anesthesia
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	1 months-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients (ASA I &#8211; II) undergoing surgery for which regional anesthesia is recommended
Key exclusion criteria	Patients with a history of diabetes mellitus, neurologic disease, or infections at the site of injection
Target sample size	2100

Research contact person
Name of lead principal investigator	Shinichi Sakura
Organization	Shimane University School of Medicine, University Hospital
Division name	Surgical Center
Address	89-1, Enya-cho, Izumo City
TEL	81-853-20-2295
Email	ssakura@med.shimane-u.ac.jp

Public contact
Name of contact person	Shinichi Sakura
Organization	Shimane University School of Medicine, University Hospital
Division name	Surgical Center
Address	89-1, Enya-cho, Izumo City
TEL	81-853-20-2295
Homepage URL
Email	ssakura@med.shimane-u.ac.jp

Sponsor
Institute	Surgical Center & Department of Anesthesiology, Shimane University School of Medicine
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	University Hospital, Shimane University School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2009 Year 07 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 07 Month 15 Day
Anticipated trial start date	2009 Year 07 Month 01 Day
Last follow-up date	2012 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2009 Year 07 Month 15 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=R000002707