UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
Region	Japan

Condition
Condition	Patients scheduled for elective unilateral total knee arthroplasty under general anesthesia and peripheral nerve block
Classification by specialty	Orthopedics Anesthesiology Operative medicine Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II,III

Assessment
Primary outcomes	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.
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Dose comparison
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Postoperative continuous femoral infusion of levobupivacaine 0.1% 4mL/h for 60 hours.
Interventions/Control_2	Postoperative continuous femoral infusion of levobupivacaine 0.05% 4mL/h for 60 hours.
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	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
Key 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
Target sample size	34

Research contact person
Name of lead principal investigator	Takaya Inoue
Organization	Osaka University Graduate School of Medicine
Division name	Department of Anesthesia and Intensive Care Medicine
Address	2-2 Yamadaoka, Suita City, Osaka, Japan
TEL	06-6879-3133
Email	inoue@anes.med.osaka-u.ac.jp

Public contact
Name of contact person	Norihiro Sakai
Organization	Osaka University Graduate School of Medicine
Division name	Department of Anesthesia and Intensive Care Medicine
Address	2-2 Yamadaoka, Suita City, Osaka, Japan
TEL	06-6879-3133
Homepage URL	http://www.med.osaka-u.ac.jp/pub/hp-crc/person_concerned/index.html
Email	sakayline@anes.med.osaka-u.ac.jp

Sponsor
Institute	Department of Anesthesia and Intensive Care Medicine, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Maruishi Pharmaceutical Co.Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	大阪大学医学部附属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2012 Year 01 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 16 Day
Anticipated trial start date	2012 Year 01 Month 18 Day
Last follow-up date	2012 Year 08 Month 09 Day
Date of closure to data entry	2012 Year 08 Month 10 Day
Date trial data considered complete	2012 Year 08 Month 15 Day
Date analysis concluded	2012 Year 09 Month 01 Day

Related information
URL releasing protocol	http://www.med.osaka-u.ac.jp/pub/anes/www/html/masui-kouza/clinical_research/study_2.html
Publication of results	Published
URL releasing results	https://journals.lww.com/ejanaesthesiology/Fulltext/2015/09000/Equivalence_of_postoperative_quadrice
Results
Other related information	August 16th, 2012 Blind Key Open

Management information
Registered date	2011 Year 12 Month 16 Day
Last modified on	2018 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008149