UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031890
Receipt number R000036409
Scientific Title Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty
Date of disclosure of the study information 2018/03/25
Last modified on 2023/04/09 21:28:43

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Basic information

Public title

Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty

Acronym

Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty

Scientific Title

Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty

Scientific Title:Acronym

Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty

Region

Japan


Condition

Condition

knee osteoarthritis or knee rheumatoid arthritis

Classification by specialty

Orthopedics Anesthesiology Operative medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim is to clarify the superior or non-inferior efficacy of the early discharge after total knee arthroplasty with administrating different volume of levobupivacaine in femoral triangle block for

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Attainment time of early discharge criteria

Key secondary outcomes

Postoperative pain score (VRS)(Postoperative 1 hour, time point per 8 hours till postoperative 72 hours)
Postoperative motor function (24, 48, 72 hours)
Postoperative rehabilitation score and muscle power(24, 48, 72 hours)
Consumption of postoperative additional analgesics(72 hours)
Complication(72 hours)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Group LV(Low volume): preoperative femoral triangle block with 0.5% levobupivacaine 5mL

Interventions/Control_2

Group HV(High volume): preoperative femoral triangle block with 0.125% levobupivacaine 20mL

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

1.Patients scheduled unilateral total knee arthroplasty at Daiyukai General Hospital
2.Adults (>=20 years) with American Society of Anaesthesiologists Physical Status Classification I-III
3.Participants were scheduled for primary unilateral TKA for osteoarthritis
4.Written informed consent is provided

Key exclusion criteria

1.Inability to communicate lucidly
2.Bilateral TKA
3.revision knee arthroplasty
4.Under 20 years old
5.Allergy to any of the drugs used in this study
6.ASA-PS > III
7.Chronic opioid use
8.Diabetes mellitus with sensory disorders
9.Neurological disability
10.Infections around femoral crease
11.Platelet < 5.0 * 10^4 /mcl
12.Pregnancy, possibility of pregnancy, or breast-feeding women
13.Contraindications to peripheral nerve blocks

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Norihiro
Middle name
Last name Sakai

Organization

Daiyukai General Hospital

Division name

Dep. Anaesthesiplogy

Zip code

491-8551

Address

1-9-9, Sakura, Ichinomiya, Aichi, Japan

TEL

+81-586-72-1211

Email

sakayline@anes.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Norihiro
Middle name
Last name Sakai

Organization

Daiyukai General Hospital

Division name

Dep. Anaesthesiplogy

Zip code

491-8551

Address

1-9-9, Sakura, Ichinomiya, Aichi, Japan

TEL

+81-586-72-1211

Homepage URL

http://www.wb.commufa.jp/dykmasui/

Email

sakayline@anes.med.osaka-u.ac.jp


Sponsor or person

Institute

Daiyukai General Hospital

Institute

Department

Personal name



Funding Source

Organization

Daiyukai General Hospital

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

Institution of Review Board of Daiyukai general Hospital

Address

1-9-9, Sakura, Ichinomiya, Aichi, Japan

Tel

+81-586-72-1211

Email

extensor2@yahoo.co.jp


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

総合大雄会病院(愛知県)


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 25 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

Completed

Date of protocol fixation

2018 Year 03 Month 01 Day

Date of IRB

2018 Year 03 Month 07 Day

Anticipated trial start date

2018 Year 03 Month 21 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 03 Month 25 Day

Last modified on

2023 Year 04 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036409


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name