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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016820
Receipt No. R000015072
Scientific Title Comparison of post-operative analgesia for gynecologic abdominal operation by transverse abdominal plain (TAP)block with or without buprenorphine
Date of disclosure of the study information 2015/03/17
Last modified on 2017/09/23

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Basic information
Public title Comparison of post-operative analgesia for gynecologic abdominal operation by transverse abdominal plain (TAP)block with or without buprenorphine
Acronym Comparison of post-operative analgesia for gynecologic abdominal operation by transverse abdominal plain (TAP)block with or without buprenorphine
Scientific Title Comparison of post-operative analgesia for gynecologic abdominal operation by transverse abdominal plain (TAP)block with or without buprenorphine
Scientific Title:Acronym Comparison of post-operative analgesia for gynecologic abdominal operation by transverse abdominal plain (TAP)block with or without buprenorphine
Region
Japan

Condition
Condition uterine myoma
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the post-operative analgesia for gynecologic abdominal surgery by transverse abdominal plain (TAP) block with or without buprenorphine
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate the difference of pain and nausea scale by TAP block with or without buprenorphine
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Without buprenorphine
Interventions/Control_2 Local anesthetics and buprenorphine
Interventions/Control_3 buprenorphine im
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Gynecological abdominal surgery
Key exclusion criteria Medicated painkiller
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makiko Komori
Organization Tokyo Women's Medical University
Division name Anesthesiology
Zip code
Address 2-1-10 Nishiogu Arakawaku Tokyo
TEL 03-3810-1111
Email mkomori@ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuharu Kodaka
Organization Tokyo Women's Medical University
Division name Anesthesiology
Zip code
Address 2-1-10 Nishiogu Arakawaku Tokyo
TEL 03-3810-1111
Homepage URL
Email kmkodaka@cb3.so-net.ne.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Tokyo Women's Medical University
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
2015 Year 03 Month 17 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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 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
2015 Year 03 Month 17 Day
Last modified on
2017 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015072

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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