UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016820 |
|---|---|
| Receipt number | 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 09:45:05 |
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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
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
kmkodaka@cb3.so-net.ne.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015072
