UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052939 |
|---|---|
| Receipt number | R000060404 |
| Scientific Title | Investigation of the spread of local anesthetic to the internal thoracic artery region injected by the transversus thoracic plane block |
| Date of disclosure of the study information | 2023/11/29 |
| Last modified on | 2023/11/29 11:13:52 |
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Basic information
Public title
Investigation of the spread of local anesthetic to the internal thoracic artery region injected by the transversus thoracic plane block
Acronym
Investigation of the spread of local anesthetic to the internal thoracic artery region injected by the transversus thoracic plane block
Scientific Title
Investigation of the spread of local anesthetic to the internal thoracic artery region injected by the transversus thoracic plane block
Scientific Title:Acronym
Investigation of the spread of local anesthetic to the internal thoracic artery region injected by the transversus thoracic plane block
Region
| Japan |
Condition
Condition
Adult patients undergoing open heart surgery (including coronary artery bypass and valve replacement)
Classification by specialty
| Vascular surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Postoperative pain after open heart surgery with median sternotomy is one of the major issues in the cardiovascular anesthesia management. At Niigata University Medical and Dental Hospital, the transversus thoracic muscle plane block (TTPB) is performed during general anesthesia induction for the purpose of postoperative pain management and preemptive analgesia effect. In coronary artery bypass graft surgery (CABG) using the internal thoracic artery as a graft, there is concern that it may affect the internal thoracic artery, if the local anesthetic administered by TTPB reaches the tissue surrounding the internal thoracic artery region. The purpose of this study was to investigate whether local anesthetic administered by TTPB reaches the internal thoracic artery region.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is to obtain objective information on the question of whether local anesthetic administered in TTPB spreads to the internal thoracic artery region.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult patients undergoing open heart surgery (including CABG and valve replacement)
Key exclusion criteria
None
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anaesthesiology
Zip code
951-8510
Address
1-757, Asahimachi-dori, Chuo ward, Niigata
TEL
+81252272328
yamatomo@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anaesthesiology
Zip code
951-8510
Address
1-757, Asahimachi-dori, Chuo ward, Niigata
TEL
+81252272328
Homepage URL
yamatomo@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Tomohiro Yamamoto
Funding Source
Organization
Niigata University
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
Ethics Committee at Niigata University Graduate School of Medical and Dental Sciences
Address
1-757, Asahimachi-dori, Chuo ward, Niigata
Tel
+81-25-227-2625
ethics@adm.niigata-u.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 | 11 | Month | 29 | 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
| 2022 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | 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
None
Management information
Registered date
| 2023 | Year | 11 | Month | 29 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060404
| Research Plan | |
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| 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 |
