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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012873
Receipt No. 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

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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
Email 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
Email sugidai@shinshu-u.ac.jp

Sponsor
Institute Department of Anesthesia and Resuscitology
Shinshu University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015041

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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