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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019904
Receipt No. 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

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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
Email 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
Email kshige@fukuoka-u.ac.jp

Sponsor
Institute fukuoka university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022376

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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