UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018809 |
|---|---|
| Receipt number | R000021759 |
| Scientific Title | The study of effectiveness of brachial plexus block under radiographic monitoring during shoulder operation |
| Date of disclosure of the study information | 2015/08/26 |
| Last modified on | 2015/08/28 20:38:18 |
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Basic information
Public title
The study of effectiveness of brachial plexus block under radiographic monitoring during shoulder operation
Acronym
The study of effectiveness of brachial plexus block under radiographic monitoring during shoulder operation
Scientific Title
The study of effectiveness of brachial plexus block under radiographic monitoring during shoulder operation
Scientific Title:Acronym
The study of effectiveness of brachial plexus block under radiographic monitoring during shoulder operation
Region
| Japan |
Condition
Condition
the patients who were scheduled to the surgery of distal clavicle or upper limb
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We studied to examine the effectiveness of brachial plexus block under radiographic monitoring
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
execution time as the interval between needle insertion and its removal at the end of the block
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
brachial plexus block under radiographic monitoring
Interventions/Control_2
brachial plexus block under ultrasound guidance
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
the patients who were scheduled to the operation of the distal clavicle or upper limb
Key exclusion criteria
Exclusion criteria included clinically significant coagulopathy, allergy to local anesthetics, severe pulmonary pathology or mental incapacity
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyuki Tanabe |
Organization
Sapporo Higashi Tokushukai Hospital
Division name
Department of Anesthesiology
Zip code
Address
3-1, Kita 33-jo Higashi 14-chome, Higashi-ku, Sapporo
TEL
011-722-1110
miyun@gj9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyuki Tanabe |
Organization
Sapporo Higashi Tokushukai Hospital
Division name
Department of Anesthesiology
Zip code
Address
3-1, Kita 33-jo Higashi 14-chome, Higashi-ku, Sapporo
TEL
011-722-1110
Homepage URL
miyun@gj9.so-net.ne.jp
Sponsor or person
Institute
Telephone East Corporation Sapporo Hospital
Institute
Department
Personal name
Funding Source
Organization
Telephone East Corporation Sapporo 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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
11-186
Org. issuing International ID_1
Telephone East Corporation Sapporo Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
NTT東日本札幌病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2011 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 26 | Day |
Last modified on
| 2015 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021759
