UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison between ultrasound-guided technique and subcutaneous infiltration technique on the intercostobrachial nerve block
Title of the study (Brief title)	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

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	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

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 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	Kaoru Hara
Organization	Matsue Seikyo Hospital
Division name	Department of Anesthesia
Address	8-8-8, Nishi-tsuda, Matsue City, Shimane
TEL	0852-23-1111
Email

Public contact
Name of contact person	Kaoru Hara
Organization	Matsue Seikyo Hospital
Division name	Department of Anesthesia
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

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	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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 01 Month 12 Day
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

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Publication of results	Unpublished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