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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000031692 |
Receipt No. | 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 | 2019/09/26 |
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 |
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Condition | ||
Condition | knee osteoarthritis
rheumatoid arthritis |
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Classification by specialty |
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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.
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |