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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026414
Receipt No. R000030345
Scientific Title intravenous dexamethasone prolong the duration of analgesia after trunk block: RCT
Date of disclosure of the study information 2017/03/06
Last modified on 2017/03/06

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Basic information
Public title intravenous dexamethasone prolong the duration of analgesia after trunk block: RCT
Acronym intravenous dexamethasone of trunk block
Scientific Title intravenous dexamethasone prolong the duration of analgesia after trunk block: RCT
Scientific Title:Acronym intravenous dexamethasone of trunk block
Region
Japan

Condition
Condition the patients recieved trunk block
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to confirm that addition of intravenousdexamethasone will prolong the duration of analgesia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the duration of first analgesics using
Key secondary outcomes VAS, QOR-40, nausea and vomiting

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 dexamethasone 3.3mg div
Interventions/Control_2 normal saline
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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 20-75 year old ptients
Key exclusion criteria 1)the patients intaking anticoagulation drug

2) the patients recieved steroids

3) DM

4)severe disease patients

5) the patients we determine as suitability
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu yoshimura
Organization Japan Community Healthcare Organization Tokuyama Central Hospital
Division name Department of Anesthesiology
Zip code
Address 1-1 Kodacho, Shunan, Yamaguchi 745-8522, Japan
TEL 0834-28-4411
Email manabu-ygc@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Yoshimura
Organization Japan Community Healthcare Organization Tokuyama Central Hospital
Division name Department of Anesthesiology,
Zip code
Address 1-1 Kodacho, Shunan, Yamaguchi 745-8522, Japan
TEL 0834-28-4411
Homepage URL
Email manabu-ygc@umin.ac.jp

Sponsor
Institute Japan Community Healthcare Organization Tokuyama Central Hospital
Institute
Department

Funding Source
Organization Japan Community Healthcare Organization Tokuyama Central Hospital
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 03 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 06 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
2017 Year 03 Month 06 Day
Last modified on
2017 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030345

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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