UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009600
Receipt number R000011261
Scientific Title Local infiltration analgesia combined with femoral nerve block in total knee arthroplasty
Date of disclosure of the study information 2012/12/21
Last modified on 2014/12/25 20:48:44

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Basic information

Public title

Local infiltration analgesia combined with femoral nerve block in total knee arthroplasty

Acronym

Local infiltration analgesia combined with femoral nerve block in total knee arthroplasty

Scientific Title

Local infiltration analgesia combined with femoral nerve block in total knee arthroplasty

Scientific Title:Acronym

Local infiltration analgesia combined with femoral nerve block in total knee arthroplasty

Region

Japan


Condition

Condition

knee osteoarthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effects of local infiltration analgesia combined with femoral nerve block in total knee arthroplasty

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

fentanyl consumption, pain visual analogue scale

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

local infiltration analgesia and femoral nerve block

Interventions/Control_2

femoral nerve block

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

40 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with knee osteoarthritis undergoing primary total knee arthroplasty

Key exclusion criteria

inflammatory arthritis
diabetis mellitus
chronic kidney disease
dementia

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiko Ikeuchi

Organization

Kochi Medical School, Kochi University

Division name

Department of orthopaedic surgery

Zip code


Address

Oko-cho Kohasu, Nankoku, Japan

TEL

088-880-2386

Email

ikeuchim@kochi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahiko Ikeuchi

Organization

Kochi Medical School, Kochi University

Division name

Department of orthopaedic surgery

Zip code


Address

Oko-cho Kohasu, Nankoku, Japan

TEL

088-866-5811

Homepage URL


Email

ikeuchim@kochi-u.ac.jp


Sponsor or person

Institute

Kochi Medical School, Kochi University

Institute

Department

Personal name



Funding Source

Organization

NA

Organization

Division

Category of Funding Organization

Other

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

2012 Year 12 Month 21 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

Open public recruiting

Date of protocol fixation

2012 Year 12 Month 21 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 25 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

2012 Year 12 Month 21 Day

Last modified on

2014 Year 12 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011261


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name