UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016019 |
|---|---|
| Receipt number | R000018626 |
| Scientific Title | Effects of catheter position of continuous nerve block on the rehabilitation of total knee arthroplasty: femoral nerve block vs adductor canal block. |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2018/06/25 10:48:46 |
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Basic information
Public title
Effects of catheter position of continuous nerve block on the rehabilitation of total knee arthroplasty: femoral nerve block vs adductor canal block.
Acronym
Post TKA rehabilitation: FNB vs ACB
Scientific Title
Effects of catheter position of continuous nerve block on the rehabilitation of total knee arthroplasty: femoral nerve block vs adductor canal block.
Scientific Title:Acronym
Post TKA rehabilitation: FNB vs ACB
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics | Anesthesiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Continuous femoral nerve block (FNB) is popular analgesia for total knee arthroplasty (TKA), however it provides motor weakness of quadriceps muscle of thigh. One of principle problem on acute rehabilitation state is swelling and persisted motor weakness of thigh. Recently, continuous adductor canal block (ACB) is noted much less motor weakness of thigh than femoral nerve block. The aim of this study is to compare the thigh swelling and recovery of motor function of thigh on acute rehabilitation of TKA between FNB and ACB.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
maximum voluntary isometric constriction of quadriceps of thigh
Key secondary outcomes
girth of thigh
post operative pain
range of motion of knee
complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
continuous femoral nerve block for 72 hours postoperatively
Interventions/Control_2
continuous adductor canal block for 72 hours postoperatively
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients planning total knee arthroplasty
Key exclusion criteria
Patients with peripheral neuropathy, palsy, obese (BMI>35), anemia, anticoagulant therapy, renal failure, and heart failure
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Nakamoto |
Organization
Osaka Rosai Hospital
Division name
Department of anesthesia and pain medicine
Zip code
Address
1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, JAPAN
TEL
072-252-3561
tnakamoto@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Nakamoto |
Organization
Osaka Rosai Hospital
Division name
Department of anesthesia and pain medicine
Zip code
Address
1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, JAPAN
TEL
072-252-3561
Homepage URL
tnakamoto@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of anesthesia and pain medicine, Osaka Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
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
大阪労災病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | 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
| 2014 | Year | 12 | Month | 22 | Day |
Last modified on
| 2018 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018626
| 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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