UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026045 |
|---|---|
| Receipt number | 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 | 2020/11/03 13:01:54 |
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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
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/
sakayline@anes.med.osaka-u.ac.jp
Sponsor or person
Institute
Daiyukai General Hospital
Dep. Anaesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.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 |
