UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019307 |
|---|---|
| Receipt number | R000022328 |
| Scientific Title | Clinical studies on the mechanism of action of local anesthetic in the levorotatory S-(-)-isomers. |
| Date of disclosure of the study information | 2015/10/13 |
| Last modified on | 2015/10/13 17:30:16 |
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Basic information
Public title
Clinical studies on the mechanism of action of local anesthetic in the levorotatory S-(-)-isomers.
Acronym
The local anesthesics of levorotatory S-(-)-isomers mechanism of action
Scientific Title
Clinical studies on the mechanism of action of local anesthetic in the levorotatory S-(-)-isomers.
Scientific Title:Acronym
The local anesthesics of levorotatory S-(-)-isomers mechanism of action
Region
| Japan |
Condition
Condition
chronic pain
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the difference of noxious and non-noxious sensations-blocking effects between racemic bupivacaine and levobupivacaine.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We investigate the difference of mechanical, thermal pain and mechanical detection thresholds between levobupivacaine and bupivacaine for 2 hours after injection.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
8
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We performe subctaneous injection of 0.025 ~0.25% bupivacaine.
Interventions/Control_2
We mesure the thresholds of pain sensation caused by von Frey hair or thermal stimulation.
Interventions/Control_3
We mesure the thresholds of tactile sensation caused by von Frey hair.
Interventions/Control_4
Washout period is at least 4 days.
Interventions/Control_5
We performe subctaneous injection of 0.025 ~0.25% levobupivacaine.
Interventions/Control_6
We mesure the thresholds of pain sensation caused by von Frey hair or thermal stimulation.
Interventions/Control_7
We mesure the thresholds of tactile sensation caused by von Frey hair.
Interventions/Control_8
Volunteers are randomly assigned to receive either levobupivacaine in the first period followed by bupivacaine in the second period or bupivacaine in the first period followed by levobupivacaine in the second period.
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
healthy volunteer
Key exclusion criteria
allergy of local anethetics
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sakamoto Akiyuki |
Organization
Shinshu university school of medicine.
Division name
anesthesiology and resuscitology
Zip code
Address
Matsumotoshi asahi 3-1-1
TEL
0263372795
akiyuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakamoto Akiyuki |
Organization
Shinshu university school of medicine
Division name
anesthesiology and resuscitology
Zip code
Address
Matsumotoshi asahi 3-1-1
TEL
0263372795
Homepage URL
akiyuki@shinshu-u.ac.jp
Sponsor or person
Institute
The department of anesthesiology and resuscitology, Shinshu university school of medicine
Institute
Department
Personal name
Funding Source
Organization
The department of anesthesiology and resuscitology, Shinshu university school of medicine
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
| 2015 | Year | 10 | Month | 13 | 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
| 2015 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 13 | 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 | 10 | Month | 10 | Day |
Last modified on
| 2015 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022328
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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