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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004155
Receipt No. 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

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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
Email

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
Email tanishi@ops.dti.ne.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004989

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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