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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016967
Receipt No. R000019696
Scientific Title Randomized Comparison Trial of Programmed Intermittent Bolus and Continuous Infusion of Epidual Analgesia for Video-Assisted Thoracoscopic Surgery for Esophagus
Date of disclosure of the study information 2015/04/30
Last modified on 2020/04/01

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Basic information
Public title Randomized Comparison Trial of Programmed Intermittent Bolus and Continuous Infusion of Epidual Analgesia for Video-Assisted Thoracoscopic Surgery for Esophagus
Acronym PIB-VATSE Study
Scientific Title Randomized Comparison Trial of Programmed Intermittent Bolus and Continuous Infusion of Epidual Analgesia for Video-Assisted Thoracoscopic Surgery for Esophagus
Scientific Title:Acronym PIB-VATSE Study
Region
Japan

Condition
Condition Esphageal Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery Anesthesiology
Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the safety and efficacy of PIB:Programmed Intermittent Bolus and CI:Continuous Infusion of epidural analgesia for Video-Assisted Thoracoscopic Surgery for Esophagus
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Frequency of Patient Controlled Analgesia(PCA),Frequency of rescue analgesia, Visual analog scale of pain,Total amount of consumpted analgesia drug
Key secondary outcomes Unscheduled interuption of epidural analgesia, occurence of complicaitons such as hypotention or bradycardia, patient satisfaction

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 For patients with esophageal cancer undergoing VATS-E, local anesthetics will be PIB resume, in which bolus does, as same hourly does of CI group, of local anesthetics will be injected every hour. Levobupicacaine and Fentanyl are used as local anesthetics. Patient-controlled analgesia (PCA) is set for additional analgesia if required. In case, PCA is not enough to treat pain, rescue iv analgesia will be injected. Morphine or tramadol are used for rescue drug. The degree of pain is also recorded by using visual analog scale (VAS).
Interventions/Control_2 For patients with esophageal cancer undergoing VATS-E, local anesthetics will be CI resume, in which the does, as same hourly does of PIB group, of local anesthetics will be injected continuously. Levobupicacaine and Fentanyl are used as local anesthetics. Patient-controlled analgesia (PCA) is set for additional analgesia if required. In case, PCA is not enough to treat pain, rescue iv analgesia will be injected. Morphine or tramadol are used for rescue drug. The degree of pain is also recorded by using visual analog scale (VAS).
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 -Scheduled for VAT-E
-age: 20 y.o.~ 80 y.o.
-general status: ASA 1 or 2
Key exclusion criteria Not indicate for Epidural anesthesia
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Otake
Organization Showa University, School of medicine
Division name Department of Anesthesiology
Zip code 142-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8000
Email otake@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Otake
Organization Showa University, School of medicine
Division name Department of Anesthesiology
Zip code 142-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8000
Homepage URL
Email otake@med.showa-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Showa University, School of medicine
Institute
Department

Funding Source
Organization Smith Medical
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Showa University, School of medicine
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel 03-3784-8000
Email ctsc.admin@ofc.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
2015 Year 04 Month 30 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 40
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 Terminated
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
2015 Year 09 Month 24 Day
Anticipated trial start date
2015 Year 10 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
2015 Year 03 Month 30 Day
Last modified on
2020 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019696

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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