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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018299
Receipt No. R000021180
Scientific Title The Combination Pectoral Nerve Block and Transversus Thoracic Muscle Plane Block is an effective analgesia for breast surgery.
Date of disclosure of the study information 2015/07/16
Last modified on 2016/12/10

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Basic information
Public title The Combination Pectoral Nerve Block and Transversus Thoracic Muscle Plane Block is an effective analgesia for breast surgery.
Acronym The Combination Pectoral Nerve Block and Transversus Thoracic Muscle Plane Block is an effective analgesia for breast surgery.
Scientific Title The Combination Pectoral Nerve Block and Transversus Thoracic Muscle Plane Block is an effective analgesia for breast surgery.
Scientific Title:Acronym The Combination Pectoral Nerve Block and Transversus Thoracic Muscle Plane Block is an effective analgesia for breast surgery.
Region
Japan

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

Objectives
Narrative objectives1 Analgesic effect in perioperative period
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analgesic scores after surgery
Key secondary outcomes Analgesic doses
complidations(nausea,vomitting)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 only PECS block
Interventions/Control_2 combination Pectoral Nerve Block and Transversus Thoracic Muscle 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 initial breast surgery
Key exclusion criteria poor communication patient
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironobu UESHIMA
Organization Showa University Hospital
Division name Anesthesiology
Zip code
Address 142-8666 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 03-3784-8875
Email ueshim@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironobu UESHIMA
Organization Showa Universtiry Hospital
Division name Anesthesiology
Zip code
Address 142-8666 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 03-3784-8875
Homepage URL
Email ueshimhi@yahoo.co.jp

Sponsor
Institute Department of Anesthesiology, Showa University Hospital
Institute
Department

Funding Source
Organization Department of Anesthesiology, Showa University Hospital
Organization
Division
Category of Funding Organization Other
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 07 Month 16 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
2015 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 07 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 07 Month 14 Day
Last modified on
2016 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021180

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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