UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the effect that highly-concentrated local anesthetic cream (Emura ® cream) gives to a venipunctural pain.
Title of the study (Brief title)	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	Daisuke Sugiyama
Organization	Shinshu University School of Medicine
Division name	Department of Anesthesia and Resuscitology
Address	3-1-1 Asahi Matsumoto
TEL	0263-37-2670
Email	sugidai@shinshu-u.ac.jp

Public contact
Name of contact person	Daisuke Sugiyama
Organization	Shinshu University School of Medicine
Division name	Department of Anesthesia and Resuscitology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000015041