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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031890
Receipt No. 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 2021/03/27

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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
Institute Daiyukai General Hospital
Institute
Department

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 No longer recruiting
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

Other
Other related information

Management information
Registered date
2018 Year 03 Month 25 Day
Last modified on
2021 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.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


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