臨床研究等提出・公開システム

Japanese

Date of registration	Aug. 23, 2017
Last modified on	Aug. 13, 2021
Trial ID	jRCT1090220306

Scientific Title	Study on objective assessment of pain in surgery patients
Public Title	Study on objective assessment of pain in surgery patients

Contact for Scientific Queries	Investigator Name	Kunihiro Nakai
	Investigator Organization	University of Fukui Hospital
	Address	23-3, Matsuokashimoaizuki, eiheiji-cho, Yoshida-gun, Fukui
	TEL	+81-776-61-8861
	E-mail	knakai@u-fukui.ac.jp
Contact for Public Queries	Contact Name	Kunihiro Nakai
	Contact Organization	University of Fukui Hospital
	Address	23-3, Matsuokashimoaizuki, eiheiji-cho, Yoshida-gun, Fukui
	TEL	+81-776-61-8861
	E-mail	knakai@u-fukui.ac.jp

Recruitment Status	COMPLETED

Date of First Enrollment		Dec. 08, 2017
Planned Number of Subjects		100
Nature of Investigation		Observational
Study Design	Description of Trial Design	Observational study
	Type of Control
	Trial Blinding Schema	open(masking not used)
	Randomized	No
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	1.Age: patients between 20 and under 80 at the time of acquiring consent 2.Gender: males and females 3.Patients scheduled to undergo local anesthesia 4.One who has no abnormality or no abnormality in the brain 5.Patients who have consented to participate in this study with free will after receiving sufficient explanation for this study and gained sufficient understandings
	Exclusion Criteria	1.A person who is taking medication for mental illness 2.A person who is already diagnosed with chronic pain 3.A patient who was judged as inappropriate as a research subject by the research director
	Minimum Age	20age old over
	Maximum Age	No limit
	Sex of Participants	Both
Trial Indication(s)		Objective evaluation of pain
Intervention(s)		Intervention type: Name of intervention: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen: detailes of teratment arms: Comparative intervention name: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Digitized values of pain based on electroencephalogram
Secondary Outcome(s)		BIS value, NRS, SFMPQ-2 value

Primary Sponsor	PaMeLa, Inc.
Secondary Sponsor

Sources of funding	PaMeLa, Inc.

Name of Ethics Committee	Fukui University Medical Research Ethics Review Committee
Address
TEL
FAX
E-Mail
Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved	Aug. 21, 2017

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Secondary Study ID	JMA-IIA00306
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	Aug. 13, 2021	(this page)	Changes
1	Aug. 23, 2017	Detail

List of change history