UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of optimal dose of local anesthetics for patient controlled coutinuous femoral nerve block with sciatic nerve block after total knee arthroplasty
Title of the study (Brief title)	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	Hideki Taninishi
Organization	Okayama University Hospital
Division name	Department of Anesthesiology and Resuscitology
Address	2-5-1, Shikata-cho, Kita-ku, Okayama city, Japan
TEL
Email

Public contact
Name of contact person	Hideki Taninishi
Organization	Okayama University Hospital
Division name	Department of Anesthesiology and Resuscitology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 08 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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