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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010105
Receipt No. R000011838
Scientific Title Postoperative quadriceps strength of continuous or patient-controlled femoral nerve block: a prospective, randomized double-blind trial after total knee arthroplasty
Date of disclosure of the study information 2013/03/01
Last modified on 2018/03/25

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Basic information
Public title Postoperative quadriceps strength of continuous or patient-controlled femoral nerve block: a prospective, randomized double-blind trial after total knee arthroplasty
Acronym Postoperative quadriceps strength of continuous or patient-controlled femoral nerve block: a prospective, randomized double-blind trial after total knee arthroplasty
Scientific Title Postoperative quadriceps strength of continuous or patient-controlled femoral nerve block: a prospective, randomized double-blind trial after total knee arthroplasty
Scientific Title:Acronym 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
1st name
Middle name
Last name Takashi Iritakenishi
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 sakayline@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/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

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
2013 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/27553442
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
2013 Year 02 Month 13 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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