UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty
Acronym	Efficacy of intravenous acetaminophen injection for pain management after TKA
Scientific Title	Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty
Scientific Title:Acronym	Efficacy of intravenous acetaminophen injection for pain management after TKA
Region	Japan

Condition
Condition	knee osteoarthritis rheumatoid arthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this research is to evaluate effectiveness of postoperative repeated intravenous administration of acetaminophen for pain after total knee arthroplasty.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain intensity at rest is measured with NRS for 24 hours after surgery.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Study group:Fentanyl sustained intravenous administration given after operation end. And use the Intravenous acetaminophen 4 times per 6 hour.Dosage is 15 mg/kg for the patient less than 50 kg in weight and 1000 mg for the patient more than 50 kg in weight.
Interventions/Control_2	Control group:Fentanyl sustained intravenous administration given after operation end.
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	Subjects eligible for inclusion in this study have to fulfill all of following criteria and be judged eligible for the study by the investigator. 1) Those who have ability to provide written consent to participate in the study. 2)Patients of American Society of Anesthesiologists (ASA) physical status classification 1 and 2 and 3. 3)Patients aged 20 years or older at the time of obtaining informed consent.
Key exclusion criteria	1)Aspirin-induced asthma or a history of diseases of aspirin-induced asthma. 2)Any subject with a past history of anaphylaxis due to acetaminophen. Any subject with blood abnormality, hepatopathy, kidney damage or cardiac dysfunction. 3)patients with liver failure. 4)Patients with NSAIDS contraindications 5)Women who are pregnant, maybe pregnant or lactation. 6)Any subject with blood abnormality, hepatopathy, kidney damage or cardiac dysfunction. 7)Any condition that, in the opinion of the investigator, would make the patient unsuitable for inclusion in the study.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kazushige Middle name Last name Seki
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Orthopedic Surgery
Zip code	755-8505
Address	1-1-1 Minamikogushi, Ube, Yamaguchi 755-0046, Japan
TEL	0836-22-2268
Email	sk0105@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Kazushige Middle name Last name Seki
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Orthopedic Surgery
Zip code	7558505
Address	1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan
TEL	0836-22-2268
Homepage URL
Email	sk0105@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University
Institute
Department

Funding Source
Organization	Department of orthropedic surgery, Yamaguchi University Graduate School of Medicine
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	Center For Clinical Research, Yamaguchi University Hospital
Address	1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan
Tel	0836-22-2428
Email	me223@yamaguchi-u.ac.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

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 12 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	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 04 Day
Date of IRB	2017 Year 12 Month 27 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2021 Year 03 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	2018 Year 03 Month 12 Day
Last modified on	2019 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035418

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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