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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012259
Receipt No. R000014202
Scientific Title Effects of anterior thoracic wall blocks in patients undergoing breast surgery: comparison of postoperative pain between patients with or without the block
Date of disclosure of the study information 2014/11/11
Last modified on 2016/06/10

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Basic information
Public title Effects of anterior thoracic wall blocks in patients undergoing breast surgery: comparison of postoperative pain between patients with or without the block
Acronym Thoracic wall blocks
Scientific Title Effects of anterior thoracic wall blocks in patients undergoing breast surgery: comparison of postoperative pain between patients with or without the block
Scientific Title:Acronym Thoracic wall blocks
Region
Japan

Condition
Condition Breast cancer that requires surgery on the chest wall
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To see the effects of ultrasound-guided thoracic wall blocks including pectoral nerves blocks) on pain during and after breast surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative VAS scores
Key secondary outcomes Postoperative opioid consumption
Intraoperative opioid consumption

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
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 thoracic wall blocks and general anesthesia
Interventions/Control_2 General anesthesia alone
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 Patients undergoing breast surgery for breast cancer
Key exclusion criteria Patients with a history of diabetes mellitus and neurologic diseases, and infection at the site of injection
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shinichi Sakura
Organization Shimane University, Faculty of Medicine, University Hospital
Division name Surgical Center
Zip code
Address 89-1, Enya-cho, Izumo City, Shimane
TEL 0853-20-2295
Email ssakura@med.shimane-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shinichi Sakura
Organization Shimane University, Faculty of Medicine, University Hospital
Division name Surgical Center
Zip code
Address 89-1, Enya-cho, Izumo City, Shimane
TEL 0853-20-2295
Homepage URL
Email ssakura@med.shimane-u.ac.jp

Sponsor
Institute Shimane University, Faculty of Medicine, University Hospital
Institute
Department

Funding Source
Organization Shimane University, Faculty of Medicine, University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Hospital Organization, Hamada Medical Center
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 島根大学医学部附属病院(島根県)、浜田医療センター(島根県)

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 11 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 11 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 11 Day
Last follow-up date
2016 Year 11 Month 10 Day
Date of closure to data entry
2016 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 11 Month 11 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=R000014202

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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