UMIN-CTR Clinical Trial

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 11 Month 03 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
2020/11/03	Protocol_merged.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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