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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-UMIN000031890 |
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Date of registration:
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25/03/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty
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Scientific title:
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Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty - Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty |
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Date of first enrolment:
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2018/03/21 |
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Target sample size:
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120 |
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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=R000036409 |
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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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Phase III
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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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Norihiro
Sakai |
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Address:
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1-9-9, Sakura, Ichinomiya, Aichi, Japan
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Telephone:
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+81-586-72-1211 |
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Email:
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sakayline@anes.med.osaka-u.ac.jp |
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Affiliation:
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Daiyukai General Hospital Dep. Anaesthesiplogy |
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Name:
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Norihiro
Sakai |
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Address:
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1-9-9, Sakura, Ichinomiya, Aichi, Japan
491-8551
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Telephone:
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+81-586-72-1211 |
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Email:
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sakayline@anes.med.osaka-u.ac.jp |
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Affiliation:
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Daiyukai General Hospital Dep. Anaesthesiplogy |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1.Inability to communicate lucidly 2.Bilateral TKA 3.revision knee arthroplasty 4.Under 20 years old 5.Allergy to any of the drugs used in this study 6.ASA-PS > III 7.Chronic opioid use 8.Diabetes mellitus with sensory disorders 9.Neurological disability 10.Infections around femoral crease 11.Platelet < 5.0 * 10^4 /mcl 12.Pregnancy, possibility of pregnancy, or breast-feeding women 13.Contraindications to peripheral nerve blocks
Age minimum:
20years-old
Age maximum:
100years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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knee osteoarthritis or knee rheumatoid arthritis
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Intervention(s)
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Group LV(Low volume): preoperative femoral triangle block with 0.5% levobupivacaine 5mL
Group HV(High volume): preoperative femoral triangle block with 0.125% levobupivacaine 20mL
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Primary Outcome(s)
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Attainment time of early discharge criteria
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Secondary Outcome(s)
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Postoperative pain score (VRS)(Postoperative 1 hour, time point per 8 hours till postoperative 72 hours) Postoperative motor function (24, 48, 72 hours) Postoperative rehabilitation score and muscle power(24, 48, 72 hours) Consumption of postoperative additional analgesics(72 hours) Complication(72 hours)
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Source(s) of Monetary Support
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Daiyukai General Hospital
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Ethics review
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Status: YES
Approval date: 07/03/2018
Contact:
extensor2@yahoo.co.jp
Institution of Review Board of Daiyukai general Hospital
+81-586-72-1211
extensor2@yahoo.co.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2019 |
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URL:
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