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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038885
Receipt No. R000044340
Scientific Title PECTORALIS BLOCK INCREASES NATURAL KILLER CELLS ABSOLUTE COUNT AND THE PERCENTAGE OF ACTIVATED NATURAL KILLER CELLS ON PATIENTS UNDERGOING BREAST CANCER SURGERY
Date of disclosure of the study information 2019/12/14
Last modified on 2019/12/14

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Basic information
Public title PECTORALIS BLOCK INCREASES NATURAL KILLER CELLS ABSOLUTE COUNT AND THE PERCENTAGE OF ACTIVATED NATURAL KILLER CELLS ON PATIENTS UNDERGOING BREAST CANCER SURGERY
Acronym PECTORALIS BLOCK INCREASES NATURAL KILLER CELLS ABSOLUTE COUNT AND THE PERCENTAGE OF ACTIVATED NATURAL KILLER CELLS ON PATIENTS UNDERGOING BREAST CANCER SURGERY
Scientific Title PECTORALIS BLOCK INCREASES NATURAL KILLER CELLS ABSOLUTE COUNT AND THE PERCENTAGE OF ACTIVATED NATURAL KILLER CELLS ON PATIENTS UNDERGOING BREAST CANCER SURGERY
Scientific Title:Acronym PECTORALIS BLOCK INCREASES NATURAL KILLER CELLS ABSOLUTE COUNT AND THE PERCENTAGE OF ACTIVATED NATURAL KILLER CELLS ON PATIENTS UNDERGOING BREAST CANCER SURGERY
Region
Asia(except Japan)

Condition
Condition Women 18-65 years who undergo elective modified radical mastectomy
Classification by specialty
Breast surgery Anesthesiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To answer how did the addition of Pectoralis block affect Natural killer cells in patients undergoing breast cancer surgery.
Basic objectives2 Others
Basic objectives -Others To evaluate how the addition of Pectoralis block affect Natural killer cells absolute count and the percentage of activated natural killer cells
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Natural killer cells absolute count and percentage of activated natural killer cells
Key secondary outcomes Total fentanyl consumption

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Ultrasound guided Pectoralis block using 0.5% Ropivacaine:
- 10 ml between pectoralis mayor muscle and pectoralis minor muscle
- 20 ml above serratus anterior muscle at the level of third rib
Interventions/Control_2 Ultrasound guided Pectoralis block using 0.9% NaCl:
- 10 ml between pectoralis mayor muscle and pectoralis minor muscle
- 20 ml above serratus anterior muscle at the level of third rib
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Female
Key inclusion criteria Undergo elective unilateral modified radical mastectomy procedure
Key exclusion criteria - decline to sign the informed consent form
- local infection and or obvious tumor in the block site
- coagulopathy
- history of allergy to medication used in this study
- history of treatment for chronic pain and/or psychiatric disorder
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Halim
Middle name
Last name Sudono
Organization Airlangga University, dr Soetomo General Hospital
Division name Anesthesiology and Intensive Care
Zip code 60286
Address Prof. Dr. Moestopo Street 6-8, surabaya, indonesia
TEL +62315501500
Email dgozaru@gmail.com

Public contact
Name of contact person
1st name Halim
Middle name
Last name Sudono
Organization Airlangga University, dr Soetomo General Hospital
Division name Anesthesiology and Intensive Care
Zip code 60286
Address Prof. Dr. Moestopo Street 6-8, Surabaya, Indonesia
TEL +6231-5501500
Homepage URL http://orcid.org/0000-0002-2906-9891
Email dgozaru@gmail.com

Sponsor
Institute Airlangga University, dr Soetomo General Hospital
Institute
Department

Funding Source
Organization Airlangga University, dr Soetomo General Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Indonesia

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Airlangga University, dr Soetomo General Hospital
Address Prof. Dr. Moestopo Street 6-8, Surabaya, indonesia
Tel +6231-5501500
Email dgozaru@gmail.com

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 Airlangga University, dr Soetomo General Hospital, Surabaya, Indonesia

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 14 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 44
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
2019 Year 05 Month 05 Day
Date of IRB
2019 Year 05 Month 14 Day
Anticipated trial start date
2019 Year 05 Month 10 Day
Last follow-up date
2019 Year 10 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 12 Month 14 Day
Last modified on
2019 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044340

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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