UMIN-CTR Clinical Trial

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
Email	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
Email	gokiten@yahoo.co.jp

Sponsor
Institute	Nagasaki Rosai 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	Nagasaki Rosai Hospital
Address	2-12-5,Setogoshi,Sasebo,Nagasaki
Tel	0956-49-2191
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033687