UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048057 |
|---|---|
| Receipt number | R000054570 |
| Scientific Title | The effectiveness of infiltration anesthesia for percutaneous transluminal angioplasty in arteriovenous fistula due to vascular stenosis on the reduction of pain |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2023/12/16 10:09:49 |
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Basic information
Public title
The effectiveness of anesthesia for percutaneous transluminal angioplasty in arteriovenous fistula on the reduction of pain
Acronym
Anesthesia for PTA in dialysis access
Scientific Title
The effectiveness of infiltration anesthesia for percutaneous transluminal angioplasty in arteriovenous fistula due to vascular stenosis on the reduction of pain
Scientific Title:Acronym
Infiltration anesthesia for PTA in dialysis access
Region
| Japan |
Condition
Condition
Pain during percutaneous transluminal angioplasty
Classification by specialty
| Vascular surgery | Urology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Infiltration anesthesia is used for pain during balloon dilation in percutaneous transluminal angioplasty (PTA). Recently, PTA has been performed under ultrasound guidance, and infiltration anesthesia has also been performed under ultrasound guidance. In the present study, we will confirm to the effectiveness of infiltration anesthesia under ultrasound guidance for PTA in arteriovenous fistula due to vascular stenosis in comparison with the blind technique.
Basic objectives2
Others
Basic objectives -Others
Effectiveness
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain visual analog scale score of the pain
Key secondary outcomes
heart rate, time required for the anethesia, side effect of the anesthesia
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
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
blind technique
Interventions/Control_2
under ultrasound guidance
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
Dialysis patients who underwent PTA during the study period
Key exclusion criteria
1)Patients who have never undergone PTA
2)Patients who did not undergo PTA more than twice during the study period
3)Patients who were unable to assess the pain (communication disability, psychiatric disorder, dementia, and sensory impairment)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Kosoku |
Organization
Meijibashi hospital
Division name
Department of urology
Zip code
580-0045
Address
Miyakenishi 1-358-3, Matsubara-shi, Osaka, Japan
TEL
072-334-8558
aki.kosoku@gmail.com
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Kosoku |
Organization
Meijibashi hospital
Division name
Department of urology
Zip code
580-0045
Address
Miyakenishi 1-358-3, Matsubara-shi, Osaka, Japan
TEL
072-334-8558
Homepage URL
aki.kosoku@gmail.com
Sponsor or person
Institute
Meijibashi hospital
Institute
Department
Personal name
Funding Source
Organization
Meijibashi hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meijibashi hospital
Address
Miyakenishi 1-358-3, Matsubara-shi, Osaka, Japan
Tel
072-334-8558
mail@meijibashi.or.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
| 2022 | Year | 07 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054570
| 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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