UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010902
Receipt number R000012757
Scientific Title A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty
Date of disclosure of the study information 2013/06/07
Last modified on 2014/09/04 20:17:24

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Basic information

Public title

A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty

Acronym

A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty

Scientific Title

A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty

Scientific Title:Acronym

A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty

Region

Japan


Condition

Condition

Osteoarthritis of knee, rheumatoid arthritis, avascular necrosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the epidural anesthesia and periarticular multimodal drug injection for pain after total knee arthroplasty.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visual analog scale score at rest at 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 32, 40, 48, 56, 64, and 72 hour after the time of complete resolution of the spinal anesthetic.

Key secondary outcomes

Visual analog scale during activity.
Complication including nausea/vomitting, skin necrosis, pruritis, respiratory depression, peroneus nerve pulsy and sugical site infection.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

An epidural anesthesia containing 2mg/ml ropivacaine 100ml and 10mg/ml morphine 0.8ml for pain after total knee arthroplasty

Interventions/Control_2

A periarticular multimodal drug injection including 7.5mg/ml ropivacaine, 10mg/ml morphine 0.8ml, bosmin 0.3mg, methylprednisolone 40mg, and ketoprofen 50mg for pain after total knee arthroplasty

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients scheduled for primary unilateral total knee arthroplasty.

Key exclusion criteria

Patients scheduled for simultaneous bilateral total knee arthroplasty.
Patients who need the heparinization perioperative period.
Patients have allergy or intolerance to one of the study drugs, renal insufficiency and prolonged QT interval on ECG.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sachiyuki Tsukada

Organization

Nekoyama miyao hospital

Division name

Orthopaedic surgery

Zip code


Address

14-7 Konan, Chuo-ku, Niigata, Niigata, 950-1151 Japan

TEL

025-282-2323

Email

s8058@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sachiyuki Tsukada

Organization

Nekoyama miyao hospital

Division name

Orthopaedic surgery

Zip code


Address

14-7 Konan, Chuo-ku, Niigata, Niigata, 950-1151 Japan

TEL

025-282-2323

Homepage URL


Email

s8058@nms.ac.jp


Sponsor or person

Institute

Nekoyama miyao 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

猫山宮尾病院(新潟県)


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 07 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://jbjs.org/content/96/17/1433

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

Completed

Date of protocol fixation

2012 Year 06 Month 25 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 11 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

2013 Year 06 Month 07 Day

Last modified on

2014 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012757


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name