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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019307
Receipt No. 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

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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
Email 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
Email akiyuki@shinshu-u.ac.jp

Sponsor
Institute The department of anesthesiology and resuscitology, Shinshu university school of medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022328

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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