UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019904 |
|---|---|
| Receipt number | R000022376 |
| Scientific Title | Development of a new system with programmed intermittent bolus for post-operative epidural analgesia |
| Date of disclosure of the study information | 2016/01/04 |
| Last modified on | 2017/03/21 13:52:14 |
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Basic information
Public title
Development of a new system with programmed intermittent bolus for post-operative epidural analgesia
Acronym
PIB for postoperative epidural analgesia
Scientific Title
Development of a new system with programmed intermittent bolus for post-operative epidural analgesia
Scientific Title:Acronym
PIB for postoperative epidural analgesia
Region
| Japan |
Condition
Condition
Chest surgery
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare analgesia effect and the reduction of local anesthesia of postoperative epidural anesthesia with PIB-PCA
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of PCA at the 24H after PCA start
Key secondary outcomes
total dose of local anesthesia at the 24H after PCA start
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
5.1mL/one time/1.5hour and PCA
Interventions/Control_2
3.4mL/H and patient controlled analgesia(PCA)
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
Lung surgery with epidural anesthesia
ASA 1-3
Key exclusion criteria
Can not do epidural anesthesia
ventilation after surgery
can not obtain informed concent
unacceptable by attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamaura Ken |
Organization
fukuoka university
Division name
Anesthesiology
Zip code
Address
7-45-1 nanakuma jyounan-ku fukuoka-city
TEL
092-801-1011
keny@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigematsu Kenji |
Organization
fukuoka university
Division name
Operating rooms
Zip code
Address
7-45-1 nanakuma jyounan-ku fukuoka-city
TEL
092-801-1011
Homepage URL
kshige@fukuoka-u.ac.jp
Sponsor or person
Institute
fukuoka university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
福岡大学病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 18 | 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
| 2015 | Year | 11 | Month | 24 | Day |
Last modified on
| 2017 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022376
