UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Postoperative quadriceps strength of continuous or patient-controlled femoral nerve block: a prospective, randomized double-blind trial after total knee arthroplasty
Title of the study (Brief title)	Postoperative quadriceps strength of continuous or patient-controlled femoral nerve block: a prospective, randomized double-blind trial 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
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We test the hypothesis that providing different infusion techniques (continuous infusion of 6mL/h or patient-controlled infusion 3mL/bolus per 30min of 0.08% levobupivacaine) produces comparable quadriceps muscle power reductions, analgesic efficacy and rehabilitation progress when uses in the femoral nerve block after total knee arthroplasty.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	The primary endpoint is the difference in maximum voluntary isometric contraction (MVIC) of the quadriceps 48 hours after surgery compared with the preoperative MVIC, expressed as a real amount of reduction and a percentage of the preoperative MVIC.
Key secondary outcomes	Secondary endpoints included postoperative knee range-of-motion, ambulatory ability, Knee Society Score, 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	Active
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	Device,equipment
Interventions/Control_1	Postoperative continuous femoral infusion of levobupivacaine 0.08% 6mL/h for 24 hours. After 24 hours of continuous infusion, switch to patient-contorolled bolus infusion of levobupivacaine 0.08% 3mL/bolus for additional 24 hours.
Interventions/Control_2	Postoperative continuous femoral infusion of levobupivacaine 0.08% 6mL/h for 48 hours, using dummy PCA botton.
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	54

Research contact person
Name of lead principal investigator	Takashi Iritakenishi
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	sakayline@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/anes/www/html/masui-kouza/clinical_research/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	Department of Anesthesia and Intensive Care Medicine, Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	2013 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 13 Day
Anticipated trial start date	2013 Year 03 Month 01 Day
Last follow-up date	2014 Year 10 Month 15 Day
Date of closure to data entry	2014 Year 10 Month 30 Day
Date trial data considered complete	2014 Year 11 Month 15 Day
Date analysis concluded	2014 Year 11 Month 25 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/27553442
Results
Other related information

Management information
Registered date	2013 Year 02 Month 23 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=R000011838