UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043286 |
|---|---|
| Receipt number | 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 | 2023/01/05 20:50:43 |
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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
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Without the ultrasound-guided fascia iliaca block
Interventions/Control_2
With the ultrasound-guided fascia iliaca block
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
| 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
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
masa-nori@nms.ac.jp
Sponsor or person
Institute
Toyohashi Heart Center
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
72
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
Completed
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
| 2023 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049419
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
