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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043286
Receipt No. R000049419
Scientific Title The effectiveness of ultrasound-guided fascia iliaca block for the pain management during the transcatheter aortic valve implantation (TAVI) procedure
Date of disclosure of the study information 2021/02/16
Last modified on 2021/02/09

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Basic information
Public title Is the nerve block toward the lower extremity effective on the transcatheter aortic valve implantation?
Acronym Transcatheter aortic valve implantation and the nerve block
Scientific Title The effectiveness of ultrasound-guided fascia iliaca block for the pain management during the transcatheter aortic valve implantation (TAVI) procedure
Scientific Title:Acronym The role of ultrasound-guided fascia iliaca block in the TAVI
Region
Japan

Condition
Condition Aortic valve stenosis
Classification by specialty
Cardiology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The current study evaluates the effectiveness of the ultrasound-guided fascia iliaca block during the transcatheter aortic valve implantation (TAVI) procedure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome is to evaluate the pain degree and the total analgesics, including opioids from the beginning to 24 hours after the TAVI procedure in patients with and without the ultrasound-guided fascia iliaca block.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 With the ultrasound-guided fascia iliaca block
The time from the ultrasound-guided fascia iliaca block to the TAVI procedure (0 min)
Interventions/Control_2 With the ultrasound-guided fascia iliaca block
The time from the ultrasound-guided fascia iliaca block to the TAVI procedure (15 min)
Interventions/Control_3 With the ultrasound-guided fascia iliaca block
The time from the ultrasound-guided fascia iliaca block to the TAVI procedure (30 min)
Interventions/Control_4 Without the ultrasound-guided fascia iliaca block
The time from the sham ultrasound-guided fascia iliaca block to the TAVI procedure (0 min)
Interventions/Control_5 Without the ultrasound-guided fascia iliaca block
The time from the sham ultrasound-guided fascia iliaca block to the TAVI procedure (15 min)
Interventions/Control_6 Without the ultrasound-guided fascia iliaca block
The time from the sham ultrasound-guided fascia iliaca block to the TAVI procedure (30 min)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients undergoing the TAVI procedure with the consent
Key exclusion criteria The patients without the consent
The patients whom the researchers judge them not eligible
Target sample size 210

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Kinoshita
Organization Hamamatsu Medical University
Division name Depts. of Anesthesiology and Intensive Care
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
TEL 053-435-2286
Email hkinoshi@krc.biglobe.ne.jp

Public contact
Name of contact person
1st name Masanori
Middle name
Last name Yamamoto
Organization Toyohashi Heart Center
Division name Dept of Cardiology
Zip code 441-8530
Address 21-1 Gobudori, Ohyama-cho, Toyohashi
TEL 0532-37-3377
Homepage URL
Email masa-nori@nms.ac.jp

Sponsor
Institute Toyohashi Heart Center
Institute
Department

Funding Source
Organization Toyohashi Heart Center
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 Toyohashi Heart Center
Address 21-1 Gobudori, Ohyama-cho, Toyohashi
Tel 0532-37-3377
Email masa-nori@nms.ac.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

Other administrative information
Date of disclosure of the study information
2021 Year 02 Month 16 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 Preinitiation
Date of protocol fixation
2021 Year 01 Month 26 Day
Date of IRB
2021 Year 01 Month 26 Day
Anticipated trial start date
2021 Year 02 Month 16 Day
Last follow-up date
2023 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
2021 Year 02 Month 09 Day
Last modified on
2021 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049419

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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