UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of the new surface anesthesia at the time of injection
Title of the study (Brief title)	Effect of the new surface anesthesia
Region	Japan

Condition
Condition	None
Classification by specialty	Oral surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the efficacy of the new surface anesthesia at the time of injection
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The reduced level of the pain of needle at the time of injection by the new surface anesthesia
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Usage of the new surface anesthesia
Interventions/Control_2
Interventions/Control_3
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 patient who will receive blood draw or infusion more than twice during observation period.
Key exclusion criteria	The patient who have allergy against lidocaine, aminobenzoate or adrenalin. The patient who have possibility of pregnancy or nursing.
Target sample size	20

Research contact person
Name of lead principal investigator	Mishima Katsuaki
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Oral and Maxillofacial Surgery
Address	1-1-1 Minamikogushi, Ube 755-8505, Japan
TEL	0836-22-2297
Email	kmishima@yamaguchi-u.ac.jp

Public contact
Name of contact person	Harada Koji
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Oral and Maxillofacial Surgery
Address	1-1-1 Minamikogushi, Ube 755-8505, Japan
TEL	0836-22-2299
Homepage URL
Email	harako@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University
Institute
Department

Funding Source
Organization	Yamaguchi University
Organization
Division
Category of Funding Organization	Government offices of other countries
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	2018 Year 01 Month 04 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 12 Month 11 Day
Anticipated trial start date	2018 Year 01 Month 04 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	2017 Year 12 Month 14 Day
Last modified on	2017 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034712