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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026045
Receipt No. R000029932
Scientific Title Femoral triangle block versus femoral nerve block for attainment of early discharge criteria after total knee arthroplasty
Date of disclosure of the study information 2017/02/08
Last modified on 2020/04/23

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Basic information
Public title Femoral triangle block versus femoral nerve block for attainment of early discharge criteria after total knee arthroplasty
Acronym Femoral triangle block versus femoral nerve block for attainment of early discharge criteria after total knee arthroplasty
Scientific Title Femoral triangle block versus femoral nerve block for attainment of early discharge criteria after total knee arthroplasty
Scientific Title:Acronym Femoral triangle block versus femoral nerve block for attainment of early discharge criteria after total knee arthroplasty
Region
Japan

Condition
Condition patients receiving total knee arthroplasty for knee osteoarthritis
Classification by specialty
Orthopedics Anesthesiology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim is to clarify that femoral trianle block was noninferior to femoral nerve block for the attainment time of early discharge criteria after total knee arthroplasty
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 (1, 24, 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 Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Group FNB: preoperative femoral nerve block with 0.25% levobupivacaine
Interventions/Control_2 Group FTB: preoperative femoral triangle nerve block with 0.25% levobupivacaine
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 160

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. Anaesthesiology
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
Dep. Anaesthesiology
Institute
Department

Funding Source
Organization Daiyukai General Hospital
Dep. Anaesthesiology
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

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 08 Day

Related information
URL releasing protocol http://u0u1.net/wWx3
Publication of results Unpublished

Result
URL related to results and publications http://u0u1.net/x3Gv
Number of participants that the trial has enrolled 179
Results
The postoperative discharge criteria were attained after (mean/SD) 63.3/20.6 h in the FNB group and 60.6/16.5 h in the pACB group. The mean difference between the two groups was 2.7 h (95% CI: -8.5 to 3.1 h; p=0.36). At 1 h post-surgery, 65/83 patients (78%)  in the pACB group and 32/79 patients (40%) in the FNB group successfully performed the SLR (p<0.0001). Other outcomes were not significantly different between groups.
Results date posted
2020 Year 04 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eligible patients were scheduled to undergo primary unilateral TKAs from March 2017 to January 2018. They had to be >20 years old and had to fulfill the American Society of Anesthesiologists 1-3 classification. Exclusion criteria included undesignated implant usage, undesignated surgical procedure, concurrent bilateral TKA, revision TKA, allergy to any drugs used in this trial, chronic opioid use, neuromuscular deficits, any infections, and any contraindications to a peripheral nerve block.
Among 182 subjects assessed for eligibility, 179 met the trial criteria. Included patients were preoperatively randomized to either the FNB or the pACB group. Randomization was performed with a computer-generated random number sequence (block size = 4), and groups were stratified by gender.
Participant flow
This trial was approved by the Institutional Review Board (No.2017-016). All patients provided written informed consent. The study was registered at the national registry (UMIN26045), and was conducted in accordance with the principles of the Helsinki Declaration. Data are presented according to the CONSORT statement.
Adverse events
None
Outcome measures
This trial was approved by the Institutional Review Board (No.2017-016). All patients provided written informed consent. The study was registered at the national registry (UMIN26045), and was conducted in accordance with the principles of the Helsinki Declaration. Data are presented according to the CONSORT statement.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 12 Month 10 Day
Date of IRB
2017 Year 02 Month 01 Day
Anticipated trial start date
2017 Year 02 Month 08 Day
Last follow-up date
2018 Year 06 Month 30 Day
Date of closure to data entry
2018 Year 06 Month 30 Day
Date trial data considered complete
2018 Year 06 Month 30 Day
Date analysis concluded
2018 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2017 Year 02 Month 08 Day
Last modified on
2020 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029932

Research Plan
Registered date File name
2020/04/23 Protocol.pdf

Research case data specifications
Registered date File name
2020/04/23 Data_Sheet.pdf

Research case data
Registered date File name
2020/04/23 Raw_Data.pdf


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