UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006715 |
|---|---|
| Receipt number | R000007659 |
| Scientific Title | Comparison of local anesthetic agents, ropivacaine and levobupivacaine, for ultrasound-guided nerve blocks. |
| Date of disclosure of the study information | 2011/11/14 |
| Last modified on | 2014/03/03 14:35:33 |
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Basic information
Public title
Comparison of local anesthetic agents, ropivacaine and levobupivacaine, for ultrasound-guided nerve blocks.
Acronym
Comparison of ultrasound-guided nerve blocks using ropivacaine and levobupivacaine.
Scientific Title
Comparison of local anesthetic agents, ropivacaine and levobupivacaine, for ultrasound-guided nerve blocks.
Scientific Title:Acronym
Comparison of ultrasound-guided nerve blocks using ropivacaine and levobupivacaine.
Region
| Japan |
Condition
Condition
diseases that require surgery in the upper and lower extremities
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of ultrasound-guided nerve blocks using ropivacaine and levobupivacaine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Time required for onset of sensory and motor blocks and duration
Key secondary outcomes
Quality of anesthesia and amount of analgesics administered during surgery, percentage of patients requiring general anesthesia, and postoperative complications.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ropivacaine is adminitered for ultrasound-guided nerve blocks.
Interventions/Control_2
Levobupivacaine is adminitered for ultrasound-guided nerve blocks.
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing surgery in upper or lower extremities.
Key exclusion criteria
patients with a history of diabetes mellitus, neurologic disease, infections at the site of injection, and who require general anesthesia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Sakura |
Organization
Shimane University, Faculty of Medecine, Univesity hospital
Division name
Surgical Center
Zip code
Address
89-1 Enya-cho, Izumo City, Simane
TEL
0853-20-2295
ssakura@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakura Sinichi |
Organization
Shimane University, Faculty of medecine, Univesity hospital
Division name
Surgical Center
Zip code
Address
89-1 Enya-cho, Izumo City, Simane
TEL
0853-20-2295
Homepage URL
ssakura@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University, Faculty of Medecine, Univesity hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Shimane University, Faculty of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
島根大学医学部附属病院（島根県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 14 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 13 | Day |
Last modified on
| 2014 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007659
| Research Plan | |
|---|---|
| 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 |
