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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032679
Receipt No. R000037265
Scientific Title Efficacy of ESP block for pneumothorax surgery
Date of disclosure of the study information 2018/05/22
Last modified on 2019/05/23

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Basic information
Public title Efficacy of ESP block for pneumothorax surgery
Acronym Efficacy of ESP block for pneumothorax surgery
Scientific Title Efficacy of ESP block for pneumothorax surgery
Scientific Title:Acronym Efficacy of ESP block for pneumothorax surgery
Region
Japan

Condition
Condition Pneumothorax
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The amount of intravenous fentanyl administration during the first 24 h after surgery
Key secondary outcomes The number of intravenous fentanyl administration during the first 24 h after surgery
Cold test

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Saline
Interventions/Control_2 20 ml of 0.75% levobupivacaine
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 Bilateral pnumothorax surgery
Key exclusion criteria Bilateral pnumothorax surgery
Emergency pnumothorax surgery
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hironobu
Middle name
Last name Ueshima
Organization Showa university hospital
Division name Anesthesiology
Zip code 142-8666
Address 1-5-8, hatanodai, shinagawa-ku, tokyo
TEL 03-3784-8575
Email ueshimhi@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Hironobu
Middle name
Last name Ueshima
Organization Showa university hospital
Division name Anesthesiology
Zip code 142-8666
Address 1-5-8, hatanodai, shinagawa-ku, tokyo
TEL 03-3784-8575
Homepage URL
Email ueshimhi@med.showa-u.ac.jp

Sponsor
Institute Showa university hospital
Institute
Department

Funding Source
Organization Showa university hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Showa university hospital
Address 1-5-8, hatanodai, shinagawa-ku, tokyo
Tel 03-3784-8575
Email ueshimhi@med.showa-u.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 05 Month 22 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 Open public recruiting
Date of protocol fixation
2018 Year 05 Month 22 Day
Date of IRB
2018 Year 05 Month 21 Day
Anticipated trial start date
2018 Year 05 Month 22 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 22 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037265

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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