UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048147 |
|---|---|
| Receipt number | R000054325 |
| Scientific Title | A comparative study of the contribution of brachial plexus block in shunt creation surgery |
| Date of disclosure of the study information | 2022/06/30 |
| Last modified on | 2022/06/23 21:54:44 |
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Basic information
Public title
A comparative study of the contribution of brachial plexus block in shunt creation surgery
Acronym
brachial plexus block test(BPB test)
Scientific Title
A comparative study of the contribution of brachial plexus block in shunt creation surgery
Scientific Title:Acronym
A nerve block comparison study
Region
| Japan |
Condition
Condition
End-stage renal failure
Classification by specialty
| Vascular surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In shunting procedures, a cardiovascular surgeon requests a nerve block when the surgical field extends into the upper arm or axilla, when the surgical field may be extensive, or when the patient is in poor general condition and general anesthesia should be avoided, although the patient is expected to be in a lot of pain. It is thought that the sympathetic nerves are also blocked when transfer anesthesia is performed, and the arteriovenous system in the operative field is dilated accordingly. If the nerve block causes the arteries in the operative field to dilate, it may have a secondary effect of facilitating the shunt procedure in addition to its analgesic effect. Therefore, we would like to measure and compare the diameters of the vascular vessels in patients who underwent shunt augmentation before and after the nerve block anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diameter of skin vein used for shunt creation before and after nerve block
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing shunting surgery, performed under nerve block
Key exclusion criteria
Patients in whom the effects of nerve block were poor (patients with severe pain in the operative field requiring intravenous analgesics or sedatives in addition to regional anesthesia, or patients who were converted to general anesthesia). Patients with complications from the administration of nerve block, such as pneumothorax or subclavian artery puncture. Patients on vasoconstrictors for poor circulation.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Tokimitsu |
| Middle name | |
| Last name | Hibino |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Anesthesiology
Zip code
430-8558
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka Prefecture,Japan
TEL
053-474-2222
zugudan@gmail.com
Public contact
Name of contact person
| 1st name | Tokimitsu |
| Middle name | |
| Last name | Hibino |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Anesthesiology
Zip code
430-8558
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka Prefecture,Japan
TEL
053-474-2222
Homepage URL
zugudan@gmail.com
Sponsor or person
Institute
Seirei Hamamatsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Seirei Hamamatsu General 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
Seirei Hamamatsu General Hospital
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka Prefecture,Japan
Tel
053-474-2222
zugudan@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
| 2022 | Year | 06 | Month | 30 | 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
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 04 | 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
A comparative study of the contribution of transfer anesthesia in shunting procedures.
To measure and compare the longitudinal diameter of the superficial vein used for shunt anastomosis before and after supraclavicular brachial plexus block + medial brachial cutaneous nerve and intercostal brachial nerve block.
Management information
Registered date
| 2022 | Year | 06 | Month | 23 | Day |
Last modified on
| 2022 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054325
| 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 |
