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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006715
Receipt No. 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

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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
Email 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
Email ssakura@med.shimane-u.ac.jp

Sponsor
Institute Shimane University, Faculty of Medecine, Univesity hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007659

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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