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Recruitment status Completed
Unique ID issued by UMIN UMIN000012899
Receipt No. R000015057
Scientific Title Effect of adjuvant Betamethasone to Ropivacaine:postoperative analgesia in ultrasound guided interscalene brachial plexus blockade for arthroscopic shoulder surgery
Date of disclosure of the study information 2014/03/10
Last modified on 2018/10/28

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Basic information
Public title Effect of adjuvant Betamethasone to Ropivacaine:postoperative analgesia in ultrasound guided interscalene
brachial plexus blockade for arthroscopic shoulder surgery
Acronym Effect of adjuvant Betamethasone to Ropivacaine
Scientific Title Effect of adjuvant Betamethasone to Ropivacaine:postoperative analgesia in ultrasound guided interscalene
brachial plexus blockade for arthroscopic shoulder surgery
Scientific Title:Acronym 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

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 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

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

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
1st name
Middle name
Last name Kunitaro Watanabe
Organization Hino Municipal Hospital
Division name anesthesiology
Zip code
Address Hino city Tamadaira 4-3-1 Tokyo Japan
TEL 042-581-2677
Email kunitarowatanabe@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunitaro Watanabe
Organization Hino Municipal Hospital
Division name anesthesiology
Zip code
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

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 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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 04 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000015057


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