UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004155 |
|---|---|
| Receipt number | R000004989 |
| Scientific Title | Evaluation of optimal dose of local anesthetics for patient controlled coutinuous femoral nerve block with sciatic nerve block after total knee arthroplasty |
| Date of disclosure of the study information | 2010/09/03 |
| Last modified on | 2016/10/30 10:08:55 |
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Basic information
Public title
Evaluation of optimal dose of local anesthetics for patient controlled coutinuous femoral nerve block with sciatic nerve block after total knee arthroplasty
Acronym
Evaluation of optimal dose of local anesthetics for patient controlled continuous femoral nerve block
Scientific Title
Evaluation of optimal dose of local anesthetics for patient controlled coutinuous femoral nerve block with sciatic nerve block after total knee arthroplasty
Scientific Title:Acronym
Evaluation of optimal dose of local anesthetics for patient controlled continuous femoral nerve block
Region
| Japan |
Condition
Condition
Patients required total knee arthroplasty
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of analgesic effect without basal administration of local anesthestics for patient-controlled femoral nerve block (with sciatic nerve block) after total knee arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analgesic effect after total knee arthroplasty, Dose of local anesthetics, Additional analgesics (time of administration, drugs), Adverse efffect of nerve blocks, Progress of rehabilitation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patient-controlled femoral nerve block with basal administration of 0.2% ropivacaine.
Basal dose: 3 ml/h, Bolus dose 5 ml,
Lock out time: 60 minutes,
Duration of administration: 4 days after the operation
Interventions/Control_2
Patient-controlled femoral nerve block without basal administration of 0.2% ropivacaine.
Basal dose: 0 ml/h, Bolus dose 8 ml,
Lock out time: 60 minutes,
Duration of administration: 4 days after the operation
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients scheduled total knee arthroplasty more than 20 years old
Key exclusion criteria
none
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Taninishi |
Organization
Okayama University Hospital
Division name
Department of Anesthesiology and Resuscitology
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Taninishi |
Organization
Okayama University Hospital
Division name
Department of Anesthesiology and Resuscitology
Zip code
Address
TEL
Homepage URL
tanishi@ops.dti.ne.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | 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
| 2010 | Year | 09 | Month | 03 | Day |
Last modified on
| 2016 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004989
