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

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 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


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

Value
https://center6.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