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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016549
Receipt No. R000019208
Scientific Title Consideration of capacity and anesthesia range of ropivacaine in Serratus Plane Block
Date of disclosure of the study information 2015/02/16
Last modified on 2016/08/17

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Basic information
Public title Consideration of capacity and anesthesia range of ropivacaine in Serratus Plane Block
Acronym Consideration of capacity and anesthesia range of ropivacaine in Serratus Plane Block
Scientific Title Consideration of capacity and anesthesia range of ropivacaine in Serratus Plane Block
Scientific Title:Acronym Consideration of capacity and anesthesia range of ropivacaine in Serratus Plane Block
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between capacity and anesthesia range of ropivacaine in Serratus Plane Block
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Loss of cold and pain sensation area after the enforcement the Serratus Plane Block
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The administration of 0.375% ropivacaine of 20ml in Serratus Plane Block
Interventions/Control_2 The administration of 0.375% ropivacaine of 40ml in Serratus Plane Block
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
80 years-old >
Gender Female
Key inclusion criteria 1,ASA-PS:1 or 2
2,Breast cancer surgery
Key exclusion criteria 1,Can not be obtained the consent and cooperation
2,Allergies to use drugs
3,Weighing less than 50kg
4,BMI is 35 or more
5,Liver disease
6,Renal disease
7,Arrhythmia
8,Opioid addiction history
9,Chronic pain disease
10,Neuromuscular disease
11,Pregnant woman
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunigou Tatsuya
Organization Obihiro Kosei Hospital
Division name Anesthesiology
Zip code
Address 1 west6 south8 Obihiro-shi, Hokkaido
TEL 0155-24-4161
Email tatsuya_9250@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunigou Tatsuya
Organization Obihiro Kosei Hospital
Division name Anesthesiology
Zip code
Address 1 west6 south8 Obihiro-shi, Hokkaido
TEL 0155-24-4161
Homepage URL
Email tatsuya_9250@yahoo.co.jp

Sponsor
Institute Obihiro Kosei Hospital
Institute
Department

Funding Source
Organization Obihiro Kosei 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
2015 Year 02 Month 16 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 Completed
Date of protocol fixation
2014 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 16 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
2015 Year 02 Month 16 Day
Last modified on
2016 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019208

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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