UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051586 |
|---|---|
| Receipt number | R000058856 |
| Scientific Title | A investigation of the correlation between the distribution of local anesthetic and the sensory area of modified thoracoabdominal nerves block through perichondrial approach (M-TAPA): a volunteer study |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2024/07/11 09:54:23 |
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Basic information
Public title
A investigation of the correlation between the distribution of local anesthetic and the sensory area of modified thoracoabdominal nerves block through perichondrial approach (M-TAPA): a volunteer study
Acronym
A investigation of the correlation between the distribution of local anesthetic and the sensory area of modified thoracoabdominal nerves block through perichondrial approach (M-TAPA): a volunteer study
Scientific Title
A investigation of the correlation between the distribution of local anesthetic and the sensory area of modified thoracoabdominal nerves block through perichondrial approach (M-TAPA): a volunteer study
Scientific Title:Acronym
A investigation of the correlation between the distribution of local anesthetic and the sensory area of modified thoracoabdominal nerves block through perichondrial approach (M-TAPA): a volunteer study
Region
| Japan |
Condition
Condition
healthy adult male volunteers
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In 2019, a novel abdominal peripheral nerve block, the modified thoracoabdominal nerve block through perichondrial approach (M-TAPA), was introduced. M-TAPA is noteworthy for its ability to anesthetize a broad area of T5-12, but its anatomic mechanism is unknown. The purpose of this study is to investigate the extent of the sensory area of M-TAPA and the anatomical mechanism providing its effect.
Basic objectives2
Others
Basic objectives -Others
To investigate the anatomical mechanism of the novel trunk block, M-TAPA.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between the sensory area and subcutaneous local anesthetic distribution confirmed by pinprick test and MRI at 60 and 120 min after M-TAPA.
Key secondary outcomes
The adverse events associated with M-TAPA
The duration of Analgesia
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
Performing bilateral M-TAPA using 0.15% levobupivacaine 25mL, epinephrine 0.13mL, and contrast (gadobutrol) approximately 0.4mL per side.
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy adult male volunteers with ASA-PS I.
Persons who voluntarily participate in this study with sufficient informed consent.
Key exclusion criteria
1. History of asthma
2. Allergy or hypersensitivity to research-related drugs
3. Patients with a history of trauma or surgery involving the muscular layer in the thoracoabdominal area
4. Patients who already have sensory abnormality in the thoracoabdominal area
5. Those who are unable to undergo MRI imaging due to claustrophobia, presence of metal in the body, etc.
6. Those who weigh less than 50 kg or have a BMI of 25 or more.
7. Patients with anatomical abnormalities at the puncture sites that may pose a risk
8. Patients with severe renal, hepatic, or hemostatic functional disorders, etc.
9. Patients taking antithrombotic drugs
10. Other subjects who are deemed inappropriate as research subjects by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Aikawa |
| Middle name | |
| Last name | Katsuhiro |
Organization
Hokkaido University Hospital
Division name
Department of Anestiesiology
Zip code
0608638
Address
North 14, West 5, Kita-ku, Sapporo
TEL
0117067861
katsuhiro.aikawa@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Aikawa |
| Middle name | |
| Last name | Katsuhiro |
Organization
Hokkaido University Hospital
Division name
Department of Anesthesiology
Zip code
0608638
Address
North 14, West 6, Kita-ku, Sapporo
TEL
0117067861
Homepage URL
katsuhiro.aikawa@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Clinical Research Administration Center
Address
North 14, West 5, Kita-ku, Sapporo
Tel
0117067636
crjimu@huhp.hokudai.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
| 2023 | Year | 10 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058856
