UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009600 |
|---|---|
| Receipt number | R000011261 |
| Scientific Title | Local infiltration analgesia combined with femoral nerve block in total knee arthroplasty |
| Date of disclosure of the study information | 2012/12/21 |
| Last modified on | 2014/12/25 20:48:44 |
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Basic information
Public title
Local infiltration analgesia combined with femoral nerve block in total knee arthroplasty
Acronym
Local infiltration analgesia combined with femoral nerve block in total knee arthroplasty
Scientific Title
Local infiltration analgesia combined with femoral nerve block in total knee arthroplasty
Scientific Title:Acronym
Local infiltration analgesia combined with femoral nerve block in total knee arthroplasty
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of local infiltration analgesia combined with femoral nerve block in total knee arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fentanyl consumption, pain visual analogue scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
local infiltration analgesia and femoral nerve block
Interventions/Control_2
femoral nerve block
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with knee osteoarthritis undergoing primary total knee arthroplasty
Key exclusion criteria
inflammatory arthritis
diabetis mellitus
chronic kidney disease
dementia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Ikeuchi |
Organization
Kochi Medical School, Kochi University
Division name
Department of orthopaedic surgery
Zip code
Address
Oko-cho Kohasu, Nankoku, Japan
TEL
088-880-2386
ikeuchim@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Ikeuchi |
Organization
Kochi Medical School, Kochi University
Division name
Department of orthopaedic surgery
Zip code
Address
Oko-cho Kohasu, Nankoku, Japan
TEL
088-866-5811
Homepage URL
ikeuchim@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 21 | Day |
Last modified on
| 2014 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011261
