UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the sensory threshold in patients using perioperative opioid.
Acronym	Examination of the sensory threshold in patients using perioperative opioid.
Scientific Title	Examination of the sensory threshold in patients using perioperative opioid.
Scientific Title:Acronym	Examination of the sensory threshold in patients using perioperative opioid.
Region	Japan

Condition
Condition	none
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the elevation of sensory threshold in patients using perioperative opioids.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The sensory and pain threshold.
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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Twice (before and after surgery)
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who weigh from 40 to 80 kilograms.
Key exclusion criteria	1.Dementia, consciousness disorder, and psychiatric disorder. 2.Aphasia, auditory disorder, and total blind. 3.Sensory disturbance. 4.Patients who can not equip an electrode because of the skin lesions. 5.Patients who use an implanted pacemaker, and a spinal cord stimulation. 6.Patients who use an implanted defibrillator. 7.Patients who use an opioid before surgery. 8.Patients who use a regional anesthesia.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Norihito Middle name Last name Hayashi
Organization	Kitasato University School of Medicine
Division name	Department of Anesthesiology
Zip code	2520374
Address	1-15-1 Kitasato Minami-ku, Sagamihara, Kanagawa
TEL	0427788111
Email	mininoriton@ybb.ne.jp

Public contact
Name of contact person	1st name Norihito Middle name Last name Hayashi
Organization	Kitasato University School of Medicine
Division name	Department of Anesthesiology
Zip code	2520374
Address	1-15-1 Kitasato Minami-ku, Sagamihara, Kanagawa
TEL	0427788111
Homepage URL
Email	mininoriton@ybb.ne.jp

Sponsor
Institute	Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	Self funding
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	Kitasato University School of Medicine
Address	1-15-1 Kitasato Minami-ku, Sagamihara, Kanagawa
Tel	0427788111
Email	rinri@med.kitasato-u.ac.jp

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 31 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	2017 Year 12 Month 20 Day
Date of IRB	2018 Year 02 Month 23 Day
Anticipated trial start date	2018 Year 01 Month 31 Day
Last follow-up date	2023 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 06 Day
Last modified on	2020 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035054