UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051264 |
|---|---|
| Receipt number | R000058462 |
| Scientific Title | Investigation of anesthetic effects based on the administration site of M-TAPA |
| Date of disclosure of the study information | 2023/06/05 |
| Last modified on | 2023/12/05 16:49:54 |
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Basic information
Public title
Investigation of anesthetic effects based on the administration site of M-TAPA
Acronym
Investigation of anesthetic effects based on the administration site of M-TAPA
Scientific Title
Investigation of anesthetic effects based on the administration site of M-TAPA
Scientific Title:Acronym
Investigation of anesthetic effects based on the administration site of M-TAPA
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess the anesthetic effects on the lateral cutaneous branches of spinal nerves depending on the injection site of M-TAPA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analgesic area
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Administer 20 mL of ropivacaine 0.2% into the injection site 1 and 2 of the M-TAPA.
Interventions/Control_2
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult volunteers with ASA-PS I.
Key exclusion criteria
Subjects were excluded if they were younger than 20-yr or older than 50-yr, categorized into ASA-PS >1, had a history of allergy to local anesthetics, had a neurological disorder affecting the corresponding region, using opioids or steroids, or were pregnant.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Ohgoshi |
Organization
Keiyu Hospital
Division name
Department of Anesthesiology
Zip code
220-8521
Address
3-7-3 Minatomirai, Nishi-ku, Yokohama, Kanagawa, 220-8521, Japan
TEL
+81-45-2218181
ohgoshi22@gmail.com
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Ohgoshi |
Organization
Keiyu Hospital
Division name
Department of Anesthesiology
Zip code
220-8521
Address
3-7-3 Minatomirai, Nishi-ku, Yokohama, Kanagawa, 220-8521, Japan
TEL
+81452218181
Homepage URL
ohgoshi22@gmail.com
Sponsor or person
Institute
Keiyu Hospital
Institute
Department
Personal name
Funding Source
Organization
Keiyu Hospital
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
Keiyu Hospital
Address
3-7-3 Minatomirai, Nishi-ku, Yokohama, Kanagawa, 220-8521, Japan
Tel
0452218181
ohgoshi22@gmail.com
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
| 2023 | Year | 06 | Month | 05 | 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
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 05 | Day |
Last modified on
| 2023 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058462
| 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 |
