UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038885 |
|---|---|
| Receipt number | 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 11:51:16 |
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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
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
dgozaru@gmail.com
Sponsor or person
Institute
Airlangga University, dr Soetomo General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044340
