UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031692 |
|---|---|
| Receipt number | R000035418 |
| Scientific Title | Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty |
| Date of disclosure of the study information | 2018/03/12 |
| Last modified on | 2023/09/15 22:37:26 |
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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
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
sk0105@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
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
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
http://www.actaorthopaedica.be/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.actaorthopaedica.be/
Number of participants that the trial has enrolled
98
Results
At time 5, the AAP group had significantly improved mean NRS score than controls.
Results date posted
| 2023 | Year | 09 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients underwent total knee arthroplasty for osteoarthritis and rheumatoid arthritis. The mean age was 73.3 years.
Participant flow
A total of 98 eligible subjects were randomized to two groups using a computerized random number generator prior to their surgery. The intravenous acetaminophen group (AAP group, n = 49) received repeated 1000 mg intravenous acetaminophen. In the AAP group, 1000 mg acetaminophen was administered intravenously (with an exception for patients under 50 kg, who were given 15 mg/kg) immediately after returning to the ward and every 6 hours thereafter on the day of the TKA. The control group (n = 49) did not receive intravenous acetaminophen.
Adverse events
nausea(9cases)
Outcome measures
The primary outcome was the postoperative numerical rating scale (NRS) pain score at rest.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 12 | Day |
Last modified on
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035418
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