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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011188
Receipt No. R000013107
Scientific Title the postoperative analgesic efficacy of transversus abdominis plane block in open retropubic prostatectomy
Date of disclosure of the study information 2013/08/01
Last modified on 2015/07/19

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Basic information
Public title the postoperative analgesic efficacy of transversus abdominis plane block in open retropubic prostatectomy
Acronym the postoperative analgesic efficacy of transversus abdominis plane block in open retropubic prostatectomy
Scientific Title the postoperative analgesic efficacy of transversus abdominis plane block in open retropubic prostatectomy
Scientific Title:Acronym the postoperative analgesic efficacy of transversus abdominis plane block in open retropubic prostatectomy
Region
Japan

Condition
Condition open retropubic prostatectomy
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 the postoperative analgesic efficacy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual Analog Scale
Key secondary outcomes

Base
Study type

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 group saline 40ml
Interventions/Control_2 group 0.25% levobupivacaine 40ml
Interventions/Control_3 group 0.125% levobupivacaine 40ml
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
99 years-old >=
Gender Male
Key inclusion criteria open retropubic prostatectomy
Key exclusion criteria severe heart dysfunction, severe kidney dysfunction,severe liver dysfunction, an allergy to local anesthesia, inappropriate to clinical trial
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironobu Ueshima
Organization Saitama Medical University International Meical Center
Division name Anesthesiology
Zip code
Address 1397-1 Yamane, Hidaka City, Saitama
TEL 042-984-4111
Email ueshimhi@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironobu Ueshima
Organization Saitama Medical University International Meical Center
Division name Anesthesiology
Zip code
Address 1397-1 Yamane, Hidaka City, Saitama
TEL 042-984-4111
Homepage URL
Email ueshimhi@yahoo.co.jp

Sponsor
Institute Department of Anesthesiology, Saitama Medical University International Medical Center
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
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

Other administrative information
Date of disclosure of the study information
2013 Year 08 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 Terminated
Date of protocol fixation
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 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
2013 Year 07 Month 14 Day
Last modified on
2015 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013107

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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