UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039346 |
|---|---|
| Receipt number | R000044876 |
| Scientific Title | The incidence of phrenic nerve palsy after Clavipectoral fascial plane block |
| Date of disclosure of the study information | 2020/01/31 |
| Last modified on | 2020/01/31 18:28:22 |
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Basic information
Public title
The incidence of phrenic nerve palsy after Clavipectoral fascial plane block
Acronym
The incidence of phrenic nerve palsy after Clavipectoral fascial plane block
Scientific Title
The incidence of phrenic nerve palsy after Clavipectoral fascial plane block
Scientific Title:Acronym
The incidence of phrenic nerve palsy after Clavipectoral fascial plane block
Region
| Japan |
Condition
Condition
Patient with clavicle fracture
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We demonstrate that phrenic palsy has not occurred after the Clavipectoral fascial plane block.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of phrenic palsy
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patient with clavicle fracture
Key exclusion criteria
Patients without consent
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Yoshimura |
Organization
Ube industries central hospital
Division name
Anesthesiology
Zip code
755-0151
Address
Nishikiwa570 Ube-city
TEL
0836-51-9980
manabu-ygc@umin.ac.jp
Public contact
Name of contact person
| 1st name | manabu |
| Middle name | |
| Last name | Yoshimura |
Organization
Ube industries Central Hospital
Division name
Aneshtesiology
Zip code
755-0151
Address
Nishikiwa750 Ube-city
TEL
0836-51-9980
Homepage URL
manabu-ygc@umin.ac.jp
Sponsor or person
Institute
Ube industries central Hospital
Institute
Department
Personal name
Funding Source
Organization
Ube industries central 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
Ube industrie central hospital
Address
Nihikiwa750 Ube-city
Tel
0836-51-9980
hiromi.kato@ube-hp.or.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
| 2020 | Year | 01 | Month | 31 | 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
| 2019 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2020 | Year | 01 | Month | 31 | Day |
Last modified on
| 2020 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044876
