UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010105 |
|---|---|
| Receipt number | 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 17:39:05 |
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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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011838
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
