UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045553 |
|---|---|
| Receipt number | R000051824 |
| Scientific Title | cost-effectiveness analysis of lidocaine patch for the preparation of arterial cannulation followed by cardio-vascular catheterization procedures |
| Date of disclosure of the study information | 2021/09/23 |
| Last modified on | 2024/01/13 09:54:56 |
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Basic information
Public title
cost-effectiveness analysis of lidocaine patch for the preparation of arterial cannulation followed by cardio-vascular catheterization procedures
Acronym
cost-effectiveness of patch anesthesia for cardiovascular catheterization
Scientific Title
cost-effectiveness analysis of lidocaine patch for the preparation of arterial cannulation followed by cardio-vascular catheterization procedures
Scientific Title:Acronym
cost-effectiveness of patch anesthesia for cardiovascular catheterization
Region
| Japan |
Condition
Condition
ischemic heart disease, valvular heart disease, peripheral arterial disease
Classification by specialty
| Medicine in general | Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the pains and the cost-effectiveness, (1) during needle puncture for anesthesia just before arterial cannulation, (2) during catheterization procedures, (3) during hemostasis time after catheterization procedure by visual analog scale between lidocaine patch anesthesia group and placebo patch group for the preparation of arterial cannulation followed by cardio-vascular catheterization
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
"pain evaluated by visual analog scale (minimum 0 cm to maximum 10 cm) and cost effectiveness analysis by incremental cost effectiveness ratio.
Pains were evaluated 3 points as below, (1) during needle puncture for anesthesia just before arterial cannulation, (2) during catheterization procedures, (3) during hemostasis time after catheterization procedure"
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intervention group, lidocaine patch local anesthesia
Interventions/Control_2
placebo group, patch tape without drugs
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
All patients undergoing cardio-vascular catheterization at our hospital (Tsukazaki Hospital) were selected as following criteria;
signed written informed consent
age between 20 and 100-years-old
both diagnostic and therapeutic procedures
Key exclusion criteria
lacking for the understanding of visual analog scale questionnaire, both transiently and permanently
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hagikura |
| Middle name | |
| Last name | Arata |
Organization
Tsukazaki Hospital
Division name
department of cardiology
Zip code
6711227
Address
68-1, Waku, Aboshi-ku, Himeji, Hyogo
TEL
+81-79-272-8555
hagikuraarata@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Hagikura |
| Middle name | |
| Last name | Arata |
Organization
Tsukazaki Hospital
Division name
department of cardiology
Zip code
6711227
Address
68-1, Waku, Aboshi-ku, Himeji, Hyogo
TEL
+81-79-272-8555
Homepage URL
hagikuraarata@hotmail.co.jp
Sponsor or person
Institute
department of cardiology, Tsukazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethics committee, Tsukazaki Hospital
Address
68-1
Tel
+81-79-272-8555
medsafe@tsukazaki-hp.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 | 09 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | 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 | 09 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051824
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
