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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016521
Receipt No. R000019184
Scientific Title Effecs of Pectoral major plane block in breast cancer patients treated with partial mastectomy and sentinel node biopsy: comparison of postoperative pain with or without the block, Randomized Controlled Trial
Date of disclosure of the study information 2015/02/12
Last modified on 2016/03/25

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Basic information
Public title Effecs of Pectoral major plane block in breast cancer patients treated with partial mastectomy and sentinel node biopsy: comparison of postoperative pain with or without the block, Randomized Controlled Trial
Acronym Effecs of Pectoral major plane block in breast cancer patients treated with partial mastectomy and sentinel node biopsy: comparison of postoperative pain with or without the block, Randomized Controlled Trial
Scientific Title Effecs of Pectoral major plane block in breast cancer patients treated with partial mastectomy and sentinel node biopsy: comparison of postoperative pain with or without the block, Randomized Controlled Trial
Scientific Title:Acronym Effecs of Pectoral major plane block in breast cancer patients treated with partial mastectomy and sentinel node biopsy: comparison of postoperative pain with or without the block, Randomized Controlled Trial
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Surgery in general Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The pectoral nerves block type 1 and 2 are novel approach to block the pectoral, intercostobrachial, 3rd to 6th intercostals, and the long thoracic nerves. But the effect of nerves block is insufficient of parasternal area, close to nipple. The anterior branches of the intercostal nerves innervates the inner aspects of pectoralis major muscles (PMm). The aim to block the anterior branches of the intercostal nerves, local anesthetic is deposited to the plane of PMm (PMPB).
Our study prospectively compares the effect of analgesia in and after partial mastectomy with sentinel lymphadenectomy using US guided Pecs block undesr general anesthesia versus PMPB with Pecs block under general anesthesia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) NRS
2) SF-MPQ2
Key secondary outcomes 1) Consumption of intraoperative analgesic agent
2) Consumption of postoperative analgesic agent
3) Severity of PONV using a Likert scale (none, mild, moderate, and severe)

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 US guided pectoral nerves block (pecs 1 block and pecs 2 block) and PMPB (pectoral major muscle plane block ) preoperatively under general anesthesia.
Interventions/Control_2 US guided pectoral nerves block (pecs 1 block and pecs 2 block) preoperatively under general anesthesia.
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

Not applicable
Gender Female
Key inclusion criteria 1. America Society of Anesthesiologist physical status (ASA-PS) 1-2
2.Brest cancer patients scheduled to partial mastectomy with sentinel lymphadenectomy under general anesthesia
3. Age>=20
4. Written informed consent
Key exclusion criteria 1. Declinin to give informed consent
2. Body mass index (BMI) >=35/kg/m2
3. History of allergy to the medications used in the study
4. Contraindication to regional anesthesia (including coagulopathy and local infection)
5. Prior breast surgery except for diagnostic biopsies
6. History of treatment for a chronic pain condition and/or psychiatric disorder
7. Considered ineligible
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sayaka Masuda
Organization Tokyo Metropolitan Ohtsuka Hospital
Division name Department of Anesthesiology
Zip code
Address 2-8-1, Minamiohtsuka, Toshima-ku, Tokyo
TEL 03+3941+3211(6098)
Email mistysky_aaa@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sayaka Masuda
Organization Tokyo Metropolitan Ohtsuka Hospital
Division name Department of Anesthesiology
Zip code
Address 2-8-1, Minamiohtsuka, Toshima-ku, Tokyo
TEL 03+3941+3211
Homepage URL
Email mistysky_aaa@yahoo.co.jp

Sponsor
Institute Tokyo Metropolitan Ohtsuka Hospital
Institute
Department

Funding Source
Organization None
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 12 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 Preinitiation
Date of protocol fixation
2015 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2015 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
2015 Year 02 Month 12 Day
Last modified on
2016 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019184

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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