UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006893
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

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Basic information

Public 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

Acronym

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

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

Scientific Title:Acronym

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

1st name
Middle name
Last name Takaya Inoue

Organization

Osaka University Graduate School of Medicine

Division name

Department of Anesthesia and Intensive Care Medicine

Zip code


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

1st name
Middle name
Last name Norihiro Sakai

Organization

Osaka University Graduate School of Medicine

Division name

Department of Anesthesia and Intensive Care Medicine

Zip code


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 or person

Institute

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

Institute

Department

Personal name



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


IRB Contact (For public release)

Organization


Address


Tel


Email



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


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


Result

URL related to results and publications

https://journals.lww.com/ejanaesthesiology/Fulltext/2015/09000/Equivalence_of_postoperative_quadrice

Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 01 Month 16 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008149


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name