Unique ID issued by UMIN | UMIN000006893 |
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Receipt number | R000008149 |
Scientific Title | Postoperative Quadriceps Motor Power of Continuous Femoral Levobupivacaine 0.05% or 0.1%: A Prospective, Randomized Double-Blind Trial in Patients After Total Knee Arthroplasty |
Date of disclosure of the study information | 2012/01/18 |
Last modified on | 2018/03/25 17:40:20 |
Postoperative Quadriceps Motor Power of Continuous Femoral Levobupivacaine 0.05% or 0.1%: A Prospective, Randomized Double-Blind Trial in Patients After Total
Knee Arthroplasty
Postoperative Quadriceps Motor Power of Continuous Femoral Levobupivacaine 0.05% or 0.1%: A Prospective, Randomized Double-Blind Trial in Patients After Total
Knee Arthroplasty
Postoperative Quadriceps Motor Power of Continuous Femoral Levobupivacaine 0.05% or 0.1%: A Prospective, Randomized Double-Blind Trial in Patients After Total
Knee Arthroplasty
Postoperative Quadriceps Motor Power of Continuous Femoral Levobupivacaine 0.05% or 0.1%: A Prospective, Randomized Double-Blind Trial in Patients After Total
Knee Arthroplasty
Japan |
Patients scheduled for elective unilateral total knee arthroplasty under general anesthesia and peripheral nerve block
Orthopedics | Anesthesiology | Operative medicine |
Rehabilitation medicine |
Others
NO
We test the hypothesis that providing levobupivacaine at different concentrations (0.1% 4ml/h vs. 0.05% 4mL/h) produces comparable quadriceps muscle power reducutions and analgesic efficacy when uses in continuous femoral nerve blocks after total knee arthroplasty.
Safety,Efficacy
Exploratory
Explanatory
Phase II,III
The primary endpoint is the difference in maximum voluntary isometric contraction (MVIC) of the quadriceps 24 hours after surgery compared with the preoperative MVIC, expressed as a percentage of the preoperative MVIC.
Secondary endpoints included postoperative knee range-of-motion, ambulatory ability, pain scores(Visual Analog Scale) at rest and during knee movement, and the consumption of additional analgesics.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Dose comparison
YES
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Treatment
Medicine |
Postoperative continuous femoral infusion of levobupivacaine 0.1% 4mL/h for 60 hours.
Postoperative continuous femoral infusion of levobupivacaine 0.05% 4mL/h for 60 hours.
20 | years-old | <= |
Not applicable |
Male and Female
1.Patients scheduled unilateral total knee arthroplasty at Osaka University Medical Hospital
2.Adults (>20 years) with American Society of Anaesthesiologists Physical Status Classification I-III
3.Participants were scheduled for primary unilateral TKA for osteoarthritis or rheumatoid arthritis
4.Written informed consent is provided
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
34
1st name | |
Middle name | |
Last name | Takaya Inoue |
Osaka University Graduate School of Medicine
Department of Anesthesia and Intensive Care Medicine
2-2 Yamadaoka, Suita City, Osaka, Japan
06-6879-3133
inoue@anes.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Norihiro Sakai |
Osaka University Graduate School of Medicine
Department of Anesthesia and Intensive Care Medicine
2-2 Yamadaoka, Suita City, Osaka, Japan
06-6879-3133
http://www.med.osaka-u.ac.jp/pub/hp-crc/person_concerned/index.html
sakayline@anes.med.osaka-u.ac.jp
Department of Anesthesia and Intensive Care Medicine, Osaka University Graduate School of Medicine
Maruishi Pharmaceutical Co.Ltd
Profit organization
Japan
None
None
NO
大阪大学医学部附属病院(大阪府)
2012 | Year | 01 | Month | 18 | Day |
http://www.med.osaka-u.ac.jp/pub/anes/www/html/masui-kouza/clinical_research/study_2.html
Published
https://journals.lww.com/ejanaesthesiology/Fulltext/2015/09000/Equivalence_of_postoperative_quadrice
Completed
2012 | Year | 01 | Month | 16 | Day |
2012 | Year | 01 | Month | 18 | Day |
2012 | Year | 08 | Month | 09 | Day |
2012 | Year | 08 | Month | 10 | Day |
2012 | Year | 08 | Month | 15 | Day |
2012 | Year | 09 | Month | 01 | Day |
August 16th, 2012 Blind Key Open
2011 | Year | 12 | Month | 16 | Day |
2018 | Year | 03 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008149
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