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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033243
Receipt No. R000037903
Scientific Title An analgesic efficacy of ultrasound-guided nerve block after Video-assisted thoracic surgery and mastectomy A prospective,Rondomized,Single-blind study
Date of disclosure of the study information 2018/07/03
Last modified on 2018/07/02

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Basic information
Public title An analgesic efficacy of ultrasound-guided nerve block after Video-assisted thoracic surgery and mastectomy
A prospective,Rondomized,Single-blind study
Acronym An analgesic efficacy of ultrasound-guided nerve block after Video-assisted thoracic surgery and mastectomy
A prospective,Rondomized,Single-blind study
Scientific Title An analgesic efficacy of ultrasound-guided nerve block after Video-assisted thoracic surgery and mastectomy
A prospective,Rondomized,Single-blind study
Scientific Title:Acronym An analgesic efficacy of ultrasound-guided nerve block after Video-assisted thoracic surgery and mastectomy
A prospective,Rondomized,Single-blind study
Region
Japan

Condition
Condition Lung cancer,breast cancer
Classification by specialty
Chest surgery Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate analgesic efficacy of Erector Spinae Plane Block(ESP block) after thoracoscopic surgery and breast cancer surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain score(Numeric Rating Score) at rest and at motion for 48 hours after surgery
Key secondary outcomes

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 ultrasound-guided ESP block(0.375% ropivacaine)
Interventions/Control_2 non ESP 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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria thoracoscopic surgery and breast cancer surgery
ASA-PS 1,2
Key exclusion criteria 1 patients with disturbance of consciousness
2 patients with serious heart, kidney,liver or lung dysfunction
3 patients with congnitive dysfunction
4 patients durling pregnancy or lactation
5 BMI over 35
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name ADACHI KUNIHIRO
Organization Southern TOHOKU General Hospital
Division name Department of anesthesiology
Zip code
Address 7-115 yatsutyamada koriyama fukushima,Japan
TEL 024-934-5322
Email akunihiro1219@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name ADACHI KUNIHIRO
Organization Southern TOHOKU General Hospital
Division name Department of anesthesiology
Zip code
Address 7-115 yatsutyamada koriyama fukushima,Japan
TEL 024-934-5322
Homepage URL
Email akunihiro1219@gmail.com

Sponsor
Institute Southern TOHOKU General 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
2018 Year 07 Month 03 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
2018 Year 07 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 03 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
2018 Year 07 Month 02 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037903

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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