UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016967 |
|---|---|
| Receipt number | 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 11:12:02 |
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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
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
otake@med.showa-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Showa University, School of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019696
