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UMIN-CTR Clinical Trial |
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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 | 2020/11/03 |
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 |
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Condition | ||||
Condition | patients receiving total knee arthroplasty for knee osteoarthritis | |||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 160 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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.
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Results date posted |
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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. |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |