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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000018931 |
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Date of registration:
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07/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial
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Scientific title:
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Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial - Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial |
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Date of first enrolment:
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2016/01/17 |
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Target sample size:
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50 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021902 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Minako Ooiwa |
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Address:
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14-7 Konan, Chuo-ku, Niigata, Niigata, 950-1151, Japan
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Telephone:
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+81252822336 |
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Email:
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yakuzai@nekoyama.or.jp |
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Affiliation:
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Nekoyama Miyao Hospital Department of Pharmacy |
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Name:
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Ooiwa Minako |
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Address:
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14-7 Konan, Chuo-ku, Niigata, Niigata, 950-1151, Japan
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Telephone:
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+81252822336 |
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Email:
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yakuzai@nekoyama.or.jp |
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Affiliation:
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Nekoyama Miyao Hospital Department of Pharmacy |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis
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Intervention(s)
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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.
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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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Complication Range of motion of the knee Consumption of rescue analgesia
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date:
Contact:
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