UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022702 |
|---|---|
| Receipt number | R000026138 |
| Scientific Title | Evaluated the position of catheter orifice and spread of drug by using Carbon dioxide contrast-enhanced ultrasonography |
| Date of disclosure of the study information | 2016/06/11 |
| Last modified on | 2016/06/15 02:06:01 |
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Basic information
Public title
Evaluated the position of catheter orifice and spread of drug by using Carbon dioxide contrast-enhanced ultrasonography
Acronym
Evaluated the position of catheter orifice by using Carbon dioxide contrast-enhanced ultrasonography
Scientific Title
Evaluated the position of catheter orifice and spread of drug by using Carbon dioxide contrast-enhanced ultrasonography
Scientific Title:Acronym
Evaluated the position of catheter orifice by using Carbon dioxide contrast-enhanced ultrasonography
Region
| Japan |
Condition
Condition
Rotator Cuff Tear
Impingement syndrome
Frozen shoulder
Osteoarthritis of the shoulder
Reccurent Dislocated shoulder
fracture of shoulder
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we attempted to evaluate the actual distance between catheter orifice and C5/C6 nerve roots by using carbon dioxide (CO2) contrast-enhanced ultrasonography technique.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We measured the distance between catheter orifice and C5/C6 nerve by CO2 contrast-enhanced ultrasonography technique in the recovery room and at 24 hours after the operation. Concurrently, patients were examined VAS score, decrease in perception of C5/C6 nerve area and manual muscle test (MMT) of biceps. We also examined the correlation between these distances and clinical scores.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
0.75 % ropivacaine 15ml was administered preoperatively via the catheter before surgery under general anesthesia. A ropivacaine 0.25% 4 ml/hour infusion with mandatory 24 hours, and on-demand half an hourly, 3 ml boluses was allowed as rescure.
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing a shoulder joint surgery, obtained the consent
Key exclusion criteria
Patients with oral anti-platelet drugs
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hayato Shimizu |
Organization
Nagayoshi General Hospital
Division name
Orthopedics
Zip code
Address
Osaka city Hirano Nagayoshinagahara 1- 2-34
TEL
06-6709-0301
hyt_1jd@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hayato Shimizu |
Organization
Nagayoshi General Hospital
Division name
Orthopedics
Zip code
Address
Osaka city Hirano Nagayoshinagahara 1- 2-34
TEL
06-6709-0301
Homepage URL
hyt_1jd@yahoo.co.jp
Sponsor or person
Institute
Nagayoshi General Hospital
Institute
Department
Personal name
Funding Source
Organization
no
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
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
| 2016 | Year | 06 | Month | 11 | 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
| 2016 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 11 | 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
| 2016 | Year | 06 | Month | 11 | Day |
Last modified on
| 2016 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026138
