UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of adjuvant Betamethasone to Ropivacaine:postoperative analgesia in ultrasound guided interscalene brachial plexus blockade for arthroscopic shoulder surgery
Title of the study (Brief title)	Effect of adjuvant Betamethasone to Ropivacaine
Region	Japan

Condition
Condition	arthroscopic shoulder surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of Adjuvant Beteamethasone with Roppivacaine
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative pain,Analgesic consumption,sensory block offset time,motor block offset time
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
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	Medicine
Interventions/Control_1	Adjuvant betamethasone with Ropivacaine group
Interventions/Control_2	Ropivacaine group
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient who ageree with Regional anethesia and General anesthesia for Limbs surgery
Key exclusion criteria	ASA4> high risk patients,Contraindications to regional anesthesia,patients who can't declare their intentions
Target sample size	40

Research contact person
Name of lead principal investigator	Kunitaro Watanabe
Organization	Hino Municipal Hospital
Division name	anesthesiology
Address	Hino city Tamadaira 4-3-1 Tokyo Japan
TEL	042-581-2677
Email	kunitarowatanabe@yahoo.co.jp

Public contact
Name of contact person	Kunitaro Watanabe
Organization	Hino Municipal Hospital
Division name	anesthesiology
Address	Hino city Tamadaira 4-3-1 Tokyo Japan
TEL	042-581-2677
Homepage URL
Email	kunitarowatanabe@yahoo.co.jp

Sponsor
Institute	Hino Municipal Hospital
Institute
Department

Funding Source
Organization	Hino Municipal Hospital
Organization
Division
Category of Funding Organization	Local Government
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	2014 Year 03 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 04 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 01 Month 19 Day
Last modified on	2018 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015057