UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018931 |
|---|---|
| Receipt number | R000021902 |
| Scientific Title | Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial |
| Date of disclosure of the study information | 2015/09/07 |
| Last modified on | 2017/05/16 11:23:19 |
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Basic information
Public title
Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial
Acronym
Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial
Scientific Title
Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial
Scientific Title:Acronym
Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial
Region
| Japan |
Condition
Condition
Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of acetaminophen on multimodal pain management after total knee arthroplasty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale for postoperative pain at rest measured at 23:00 of day of surgery, 5:00, 11:00, 17:00, and 23:00 of one day after surgery, 5:00, 11:00, 17:00, and 23:00 of two days after surgery, and 5:00 of three days after surgery.
Key secondary outcomes
Complication
Range of motion of the knee
Consumption of rescue analgesia
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
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1000 mg of intravenous acetaminophen (100 ml) after total knee arthroplasty at 23:00 of day of surgery, 5:00, 11:00, 17:00, and 23:00 of one day after surgery, 5:00, 11:00, 17:00, and 23:00 of two days after surgery, and 5:00 of three days after surgery.
Interventions/Control_2
100ml of intravenous normal saline after total knee arthroplasty at 23:00 of day of surgery, 5:00, 11:00, 17:00, and 23:00 of one day after surgery, 5:00, 11:00, 17:00, and 23:00 of two days after surgery, and 5:00 of three days after surgery.
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
Male and Female
Key inclusion criteria
Patients scheduled for unilateral total knee arthroplasty
Key exclusion criteria
Patients scheduled for simultaneous bilateral total knee arthroplasty.
Patients scheduled for unilateral total knee arthroplasty combined with implant removal.
Patients who had allergy or intolerance to one of the study drugs.
Patients who received anticoagulant therapy.
Patients who had poorly controlled diabetic mellitus, renal insufficiency, liver dysfunction and prolonged QT interval on ECG.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minako Ooiwa |
Organization
Nekoyama Miyao Hospital
Division name
Department of Pharmacy
Zip code
Address
14-7 Konan, Chuo-ku, Niigata, Niigata, 950-1151, Japan
TEL
+81252822336
yakuzai@nekoyama.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ooiwa Minako |
Organization
Nekoyama Miyao Hospital
Division name
Department of Pharmacy
Zip code
Address
14-7 Konan, Chuo-ku, Niigata, Niigata, 950-1151, Japan
TEL
+81252822336
Homepage URL
yakuzai@nekoyama.or.jp
Sponsor or person
Institute
Nekoyama Miyao 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
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 | 09 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.arthroplastyjournal.org/article/S0883-5403(17)30419-9/abstract
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
| 2015 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 17 | 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 | 09 | Month | 07 | Day |
Last modified on
| 2017 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021902
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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