UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004248 |
|---|---|
| Receipt number | R000005102 |
| Scientific Title | A clinical trial of differential nerve block with lidocaine derivatives in healthy human volunteers |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2014/06/07 11:34:39 |
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Basic information
Public title
A clinical trial of differential nerve block with lidocaine derivatives in healthy human volunteers
Acronym
Differential nerve block with lidocaine derivatives
Scientific Title
A clinical trial of differential nerve block with lidocaine derivatives in healthy human volunteers
Scientific Title:Acronym
Differential nerve block with lidocaine derivatives
Region
| Japan |
Condition
Condition
regional anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the potentials for differential nerve block with lidocaine derivative sodium channel blockers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For evaluating if lidocaine derivatives tested in this trial can produce differential block, mechanical, thermal, cold, and touch sensation are assessed
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lidocain derivatives and capsaicin are injected subcutaneously into the forearm of healthy human volunteers
Interventions/Control_2
Physiological saline and capsaicin are injected subcutaneously into the forearm of healthy human volunteers
Interventions/Control_3
Thermal stimulation (45 degree) is applied on the site where lidocaine derivatives have been injected
Interventions/Control_4
Thermal stimulation (45 degree) is applied on the site where physiological saline has been injected
Interventions/Control_5
Tiny incision on the site where lidocaine derivatives have been injected
Interventions/Control_6
Tiny incision on the site where physiological saline has been injected
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy human volunteer
Key exclusion criteria
except above
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiyuki Sakamoto |
Organization
Shinshu Univ. school of medicine
Division name
Dept. anesthesiology and resuscitology
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano
TEL
0263352734
akiyuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakamoto Akiyuki |
Organization
Shinshu Univ. school of medicine
Division name
Dept. anesthesiology and resuscitology
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano
TEL
0263352734
Homepage URL
akiyuki@shinshu-u.ac.jp
Sponsor or person
Institute
Dept. anesthesiology and resuscitology, Shinshu Univ. school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2010 | Year | 10 | Month | 01 | 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
| 2010 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
| 2010 | Year | 09 | Month | 22 | Day |
Last modified on
| 2014 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005102
