UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012873 |
|---|---|
| Receipt number | R000015041 |
| Scientific Title | Examination of the effect that highly-concentrated local anesthetic cream (Emura ® cream) gives to a venipunctural pain. |
| Date of disclosure of the study information | 2014/01/16 |
| Last modified on | 2018/02/06 03:09:36 |
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Basic information
Public title
Examination of the effect that highly-concentrated local anesthetic cream (Emura ® cream) gives to a venipunctural pain.
Acronym
Examination of the effect that highly-concentrated local anesthetic cream (Emura ® cream) gives to a venipunctural pain.
Scientific Title
Examination of the effect that highly-concentrated local anesthetic cream (Emura ® cream) gives to a venipunctural pain.
Scientific Title:Acronym
Examination of the effect that highly-concentrated local anesthetic cream (Emura ® cream) gives to a venipunctural pain.
Region
| Japan |
Condition
Condition
The patient who has an operation under anesthesia department management
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An intravenous drug is generally used on the occasion of general anesthesia introduction, and therefore methods (I cool a local anesthesia seal, a local anaesthetic injection warm) various as a method to reduce a pain with the puncture are performed, and, however, it comes to have no effect, and itself has a problem such as being painful with the local anaesthetic injection when I changed a puncture part with the local anesthesia seal.
Highly-concentrated local anesthetic cream was not released until now in Japan, but the Emura ® cream was released recently, and painkilling with the laser treatment is adaptation, and this drug is intended that there is not the adaptation to an ache and examines the effect for the pain of the ache at puncture by this high density local anesthetic cream application at the puncture with the injection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
I evaluate it by a change of Visual Analogue Scale, the vital signs after securing of vein success
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control group: I secure blood vessel with a 22G vein custody needle without anesthesia
Interventions/Control_2
Local anesthesia group: I puncture 1% lidocaine after hypodermic injection with a 25G needle
Interventions/Control_3
Emura group: After having applied Emura ® cream 20 minutes before venepuncture, I puncture it
I evaluate it by a change of VAS, the vital signs after securing of vein success
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The adult patient who has an operation only by general anesthesia under anesthesia department management
Key exclusion criteria
Patient with preoperation state of the American anesthesia society more than 3
The patient who uses other anesthesia together
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Sugiyama |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesia and Resuscitology
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2670
sugidai@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Sugiyama |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesia and Resuscitology
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2670
Homepage URL
sugidai@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Anesthesia and Resuscitology
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesia 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
| 2014 | Year | 01 | Month | 16 | 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
| 2014 | Year | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 20 | 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 | 16 | Day |
Last modified on
| 2018 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015041
