UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029487 |
|---|---|
| Receipt number | R000033687 |
| Scientific Title | Comparison of the effect on the postoperative pain between intravenous acetaminophen and flurbiprofen after total knee arthroplasty: a randomized controlled trial |
| Date of disclosure of the study information | 2017/10/10 |
| Last modified on | 2020/04/05 16:31:05 |
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Basic information
Public title
Comparison of the effect on the postoperative pain between intravenous acetaminophen and flurbiprofen after total knee arthroplasty: a randomized controlled trial
Acronym
Comparison of the effect on the postoperative pain between intravenous acetaminophen and flurbiprofen after total knee arthroplasty: a randomized controlled trial
Scientific Title
Comparison of the effect on the postoperative pain between intravenous acetaminophen and flurbiprofen after total knee arthroplasty: a randomized controlled trial
Scientific Title:Acronym
Comparison of the effect on the postoperative pain between intravenous acetaminophen and flurbiprofen after total knee arthroplasty: a randomized controlled trial
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is the comparison of the effect on the postoperative pain between intravenous acetaminophen and flurbiprofen after total knee arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pain evaluated by Numerical Rating Scale (NRS) during first 24 h after total knee arthroplasty.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous acetaminophen (1000mg) administration 15 minutes before the end of operation, and 6, 12, 18, and 24 hours after the operation.
Interventions/Control_2
Flurbiprofen (50mg) administration 15 minutes before the end of operation, and 6, 12, 18, and 24 hours after the operation.
Interventions/Control_3
Saline (5ml) administration 15 minutes before the end of operation, and after 6, 12, 18, and 24 hours after the operation.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients weighing 50-70 kg and undergoing elective total knee arthroplasty.
Key exclusion criteria
1. ASA physical status 3-6
2. Liver or renal dysfunction
3. Past history of peptic ulcer or asthma
4. Allergy to acetaminophen or NSAIDs or local anesthetics
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Terao |
Organization
Nagasaki Rosai Hospital
Division name
Department of anesthesia
Zip code
857-0134
Address
2-12-5, Setogoe, Sasebo, Nagasaki, Japan
TEL
0956-49-2191
yoterao@na-robyo.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Kasai |
Organization
Nagasaki Rosai Hospital
Division name
Department of anesthesia
Zip code
857-0134
Address
2-12-5, Setogoe, Sasebo, Nagasaki, Japan
TEL
0956-49-2191
Homepage URL
gokiten@yahoo.co.jp
Sponsor or person
Institute
Nagasaki Rosai Hospital
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
Nagasaki Rosai Hospital
Address
2-12-5,Setogoshi,Sasebo,Nagasaki
Tel
0956-49-2191
shomu@na-robyo.jp
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
長崎労災病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 10 | 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
75
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
| 2017 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 10 | Day |
Last modified on
| 2020 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033687
| 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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| Registered date | File name |
