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


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 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


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

Value
https://center6.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