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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033056
Receipt No. R000037690
Scientific Title Consideration of the validity of Erector Spinae Plane Block to trunk surgery
Date of disclosure of the study information 2018/06/19
Last modified on 2019/04/25

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Basic information
Public title Consideration of the validity of Erector Spinae Plane Block to trunk surgery
Acronym Consideration of the validity of ESPB to trunk surgery
Scientific Title Consideration of the validity of Erector Spinae Plane Block to trunk surgery
Scientific Title:Acronym Consideration of the validity of ESPB to trunk surgery
Region
Japan

Condition
Condition breast surgery / spine surgery / laparoscopic colon resection
Classification by specialty
Gastrointestinal surgery Breast surgery Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 do ESPB where it seems effective to breast cancer, spine surgery and colon cancer, and estimate their validity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes NRS to a post-operatively for 48 hours
Key secondary outcomes

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 Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Erector Spinae Plane Block is performed before the surgery.
Interventions/Control_2 A usual analgesia is performed.
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 Male and Female
Key inclusion criteria The breast surgery, spine surgery and colon cancer operation under the laparoscope performed at my hospital in the period.
Key exclusion criteria (1) Patient of a breast cancer operation of both sides
(2) Patient of a vertebrae cervicales operation
(3) Patient with a pathological change which doesn't suit that a tap has skin in the tap part
(4) Patient with the past allergic to local anesthetics
(5) The emergency operation patient who can think operation of a hand skill is dangerous
(6) Additionally the patient who judged that a study person in charge was unsuitable as a subject
Target sample size 30

Research contact person
Name of lead principal investigator
1st name masateru
Middle name
Last name kumemura
Organization Juntendo University Shizuoka Hospital
Division name Anesthesiology
Zip code 4102295
Address 1129 Nagaoka. Izunokuni-city Shizuoka, 410-2295, Japan
TEL 055-948-3111
Email m-kumemura@juntendo.ac.jp

Public contact
Name of contact person
1st name masateru
Middle name
Last name kumemura
Organization Juntendo University Shizuoka Hospital
Division name Anesthesiology
Zip code 4102295
Address 1129 Nagaoka. Izunokuni-city Shizuoka, 410-2295, Japan
TEL 055-948-3111
Homepage URL
Email m-kumemura@juntendo.ac.jp

Sponsor
Institute Juntendo University Shizuoka Hospital
Institute
Department

Funding Source
Organization Juntendo University Shizuoka Hospital
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 Juntendo University Shizuoka Hospital
Address 1129 Nagaoka. Izunokuni-city Shizuoka, 410-2295, Japan
Tel 055-948-3111
Email m-kumemura@juntendo.ac.jp

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
2018 Year 06 Month 19 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 146
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
2018 Year 06 Month 05 Day
Date of IRB
2018 Year 06 Month 05 Day
Anticipated trial start date
2018 Year 06 Month 06 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 04 Month 24 Day
Date trial data considered complete
2019 Year 04 Month 24 Day
Date analysis concluded
2019 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 06 Month 19 Day
Last modified on
2019 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037690

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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