UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052388 |
|---|---|
| Receipt number | R000059805 |
| Scientific Title | risk factors for phrenic nerve palsy associated with supraclavicular brachial plexus block. |
| Date of disclosure of the study information | 2023/10/06 |
| Last modified on | 2024/05/16 10:10:41 |
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Basic information
Public title
research for respiratory complications associated with supraclavicular brachial plexus block
Acronym
research for respiratory complications associated with supraclavicular brachial plexus block.
Scientific Title
risk factors for phrenic nerve palsy associated with supraclavicular brachial plexus block.
Scientific Title:Acronym
risk factors for phrenic nerve palsy associated with supraclavicular brachial plexus block.
Region
| Japan |
Condition
Condition
the trial cohort consisted of aged 20-70 years with American Society of Anesthesiologists (ASA) physical status 1 or 2 scheduled for orthopedic upper limb surgery with regional anesthesia.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We hypothesized that the depth of brachial plexus could be associated with incidence of phrenic nerve palsy.
Basic objectives2
Others
Basic objectives -Others
sonographic assessment of phrenic nerve palsy associated with supraclavicular brachial plexus block
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the correlation between incidence of phrenic nerve palsy and depth of brachial plexus from the skin.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients of orthopedic upper limb surgery with regional anesthesia.
Key exclusion criteria
The exclusion criteria include hypersensitivity to anesthetic agents, preexisting neuropathy on surgical limb, pulmonary complications, coagulopathy, infection on block site, pregnancy, conversion to general anesthesia, and patient refusal.
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Hida |
Organization
Niigata prefectural tokamachi Hospital
Division name
department of anesthesiology
Zip code
9480065
Address
3 chome minami, 32-9, takada, tokamachi city, niigata prefecture
TEL
0257575566
seijihida@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Hida |
Organization
Niigata prefectural tokamachi Hospital
Division name
department of anesthesiology
Zip code
9480065
Address
3 chome minami, 32-9, takada, tokamachi city, niigata prefecture
TEL
0257575566
Homepage URL
seijihida@yahoo.co.jp
Sponsor or person
Institute
Niigata prefectural tokamachi hospital
Institute
Department
Personal name
Funding Source
Organization
Niigata prefectural tokamachi 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
niigata prefectural tokamachi hospital
Address
3 chome minami, 32-9, takada, tokamachi city, niigata prefecture
Tel
0257575566
seijihida@yahoo.co.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 | 06 | 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
| 2023 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
we evaluate the correlation between the depth of brachial plexus and the incidence of phrenic nerve palsy using ultrasound.
Management information
Registered date
| 2023 | Year | 10 | Month | 03 | Day |
Last modified on
| 2024 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059805
| 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 |
