UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015334 |
|---|---|
| Receipt number | R000017825 |
| Scientific Title | Analgesic effect of intravenous acetaminophen and flurbiprofen after elective breast surgery |
| Date of disclosure of the study information | 2014/10/03 |
| Last modified on | 2015/10/12 20:43:40 |
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Basic information
Public title
Analgesic effect of intravenous acetaminophen and flurbiprofen after elective breast surgery
Acronym
Analgesic effect of intravenous acetaminophen and flurbiprofen after elective breast surgery
Scientific Title
Analgesic effect of intravenous acetaminophen and flurbiprofen after elective breast surgery
Scientific Title:Acronym
Analgesic effect of intravenous acetaminophen and flurbiprofen after elective breast surgery
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of our study is to compare the analgesic effects of an intravenous acetaminophen and flurbiprofen, an intravenous non-steroidal anti-inflammatory drugs, after elective breast surgeries.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pain evaluation performed by visual analog scale (VAS) after 3 hours, 6 hours and 24 hours postoperatively.
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
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intravenous acetaminophen (1000mg) injection 15minutes before the end of surgery, and after 6 hours, 12hours postoperatively
Interventions/Control_2
flurbiprofen (50mg) injection 15minutes before the end of surgery, and after 6 hours, 12hours postoperatively
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
| Not applicable |
Gender
Female
Key inclusion criteria
a patient for elective partial mastectomy
a 50-65 kilograms adult
Key exclusion criteria
past history of peptic ulcer
eGFR under 60 ml/min
an allergy to propionic acid-based NSAIDs
an allergy to acetaminophen
a pregnant woman
past history of Aspirin-induced asthma
liver cirrhosis
contraindication to propofol
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Yamamoto |
Organization
Kumamoto university hospital
Division name
Department of anesthesiology
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
096-373-5275
yamyam@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Nonaka |
Organization
Kumamoto university hospital
Division name
Department of anesthesiology
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
096-373-5275
Homepage URL
end_of_uruma@yahoo.co.jp
Sponsor or person
Institute
Department of anesthesiology, Kumamoto 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
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
| 2014 | Year | 10 | Month | 03 | 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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 03 | Day |
Last modified on
| 2015 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017825
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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