UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040054
Receipt No. R000045668
Scientific Title The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block
Date of disclosure of the study information 2020/04/04
Last modified on 2020/04/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block
Acronym The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block
Scientific Title The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block
Scientific Title:Acronym The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block
Region
Japan

Condition
Condition knee osteoarthritis or knee rheumatoid arthritis
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim is to clarify the equivalent or non-inferior efficacy of the early discharge after total knee arthroplasty using popliteal plexus block or tibial nerve block for the reduction of the dorsal aspect of the knee.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Early discharge readiness
2.
Key secondary outcomes Postoperative pain score (NRS): Postoperative 1 hour, time point per 12 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 Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Popliteal Plexus Block with 0.25% levobupivacaine 10 mL
Interventions/Control_2 Tibial Nerve Block(TNB) with 0.25% levobupivacaine 10 mL
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 YES
Study ID_1 2020-001
Org. issuing International ID_1 Daiyukai General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 総合大雄会病院

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 04 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 Enrolling by invitation
Date of protocol fixation
2020 Year 01 Month 15 Day
Date of IRB
2020 Year 03 Month 07 Day
Anticipated trial start date
2020 Year 04 Month 06 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 04 Day
Last modified on
2020 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045668

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.