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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036574
Receipt No. R000041671
Scientific Title A randomized prospective comparison of programmed intermittent bolus with continuous infusion for ultrasound-guided erector spinae plane block in video-assisted thoracic surgery
Date of disclosure of the study information 2019/05/01
Last modified on 2019/04/22

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Basic information
Public title A randomized prospective comparison of programmed intermittent bolus with continuous infusion for ultrasound-guided erector spinae plane block in video-assisted thoracic surgery
Acronym A randomized prospective study of two different infusion protocol of ultrasound-guided erector spinae plane block
Scientific Title A randomized prospective comparison of programmed intermittent bolus with continuous infusion for ultrasound-guided erector spinae plane block in video-assisted thoracic surgery
Scientific Title:Acronym A randomized prospective study of two different infusion protocol of ultrasound-guided erector spinae plane block
Region
Japan

Condition
Condition Lung tumor
Classification by specialty
Chest surgery Anesthesiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Verifying the difference of anesthetized dermatomes between two different drug infusion protocol for ultrasound-guided erecor spinae plane block in video-assisted thoracic surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of anesthetized dermatomes at 20h after the initial bolus injection
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Using programmed intermittent bolus infusion postoperatively
Interventions/Control_2 Using continuous infusion postoperatively
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Provided written informed consent
2.American Society of Anesthesiologists physical status 1-3
3.Scheduled to undergo complete video-assisted thoracoscopic surgery for lung cancer.
Key exclusion criteria allergy to local anesthetics
BMI>30
age< 20 or >80
Liver function disorder
Renal function disorder (eGFR<50)
History of past ipsilateral thoracotomy
Normally using opioid analgesics
Treated mental or neurological disorders
Allergy to acetaminophen, NSAIDs, and fentanyl.
Difficulty in adequate verbal communication
Thoracotomy with rib cutting or pleurectomy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Taro
Middle name
Last name Fujitani
Organization Ehime Prefectural Central Hospital
Division name Department of Anesthesiology and Critical Care
Zip code 790-0024
Address 83 Kasuga-machi Matsuyama Ehime Japan 790-0024
TEL 089-947-1111
Email suko1231@yahoo.co.jp

Public contact
Name of contact person
1st name Yasuko
Middle name
Last name Taketa
Organization Ehime Prefectural Cenral Hospital
Division name Department of Anesthesia and Critical Care
Zip code 790-0024
Address 83 Kasuga-machi Matsuyama Ehime Japan 790-0024
TEL 089-947-1111
Homepage URL
Email suko1231@yahoo.co.jp

Sponsor
Institute Ehime Prefectural Central Hospital
Institute
Department

Funding Source
Organization None
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 Institutional review board of Ehime Prefectural Central Hospital
Address 83 Kasuga-machi Matsuyama Ehime Japan 790-0024
Tel 089-947-1111
Email suko1231@yahoo.co.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
2019 Year 05 Month 01 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
2019 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 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
2019 Year 04 Month 22 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041671

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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