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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018931
Receipt No. 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

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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
Email 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
Email yakuzai@nekoyama.or.jp

Sponsor
Institute Nekoyama Miyao Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021902

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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