UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012897 |
|---|---|
| Receipt number | R000015054 |
| Scientific Title | Comparison between Levobupivacaine and Ropivacaine:Ultrasound-guided peripheral nerve block for limbs surgery |
| Date of disclosure of the study information | 2014/03/10 |
| Last modified on | 2018/10/28 21:24:39 |
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Basic information
Public title
Comparison between Levobupivacaine and Ropivacaine:Ultrasound-guided peripheral nerve block for limbs surgery
Acronym
Comparison between Levobupivacaine and Ropivacaine
Scientific Title
Comparison between Levobupivacaine and Ropivacaine:Ultrasound-guided peripheral nerve block for limbs surgery
Scientific Title:Acronym
Comparison between Levobupivacaine and Ropivacaine
Region
| Japan |
Condition
Condition
Limbs surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison between Levobupivacaine and Ropivacaine
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pain,Analgesic consumption,sensory block offset time,motor block offset time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
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
levobupivacaine group
Interventions/Control_2
Ropivacaine group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who ageree with Regional anethesia and General anesthesia for Limbs surgery
Key exclusion criteria
ASA4> high risk patients,Contraindications to regional anesthesia,patients who can't declare their intentions,whwen failed to perform nerve block
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunitaro Watanabe |
Organization
Hino Municipal Hospital
Division name
anesthesiology
Zip code
Address
Hino city Tamadaira 4-3-1 Tokyo Japan
TEL
042-581-2677
kunitarowatanabe@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunitaro Watanabe |
Organization
Hino Municipal Hospital
Division name
anesthesiology
Zip code
Address
Hino city Tamadaira 4-3-1 Tokyo Japan
TEL
042-581-2677
Homepage URL
kunitarowatanabe@yahoo.co.jp
Sponsor or person
Institute
Hino Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Hino Municipal Hospital
Organization
Division
Category of Funding Organization
Local Government
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
| 2014 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | 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
| 2014 | Year | 01 | Month | 19 | Day |
Last modified on
| 2018 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015054
