UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Opioid Tolerance: Can it be quantitatively assessed?
Title of the study (Brief title)	Assessment of Opioid Tolerance
Region	Japan

Condition
Condition	Elective surgery patients
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of pain sensation pressure and non-respiratory sensation period amongst opioid naive and weak/strong opioid dependent users.
Basic objectives2	Others
Basic objectives -Others	Safe use of peri-operative opioids.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of pain sensation pressure and non-respiratory sensation period after bolus administration of fentanyl amongst opioid naive and tolerant patients.
Key secondary outcomes	Comparison of the changes in pain sensation pressure and non-respiratory sensation period after bolus administration of fentanyl amongst opioid naive and tolerant patients.

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	No treatment control
Interventions/Control_2	Opioid consuming patient for cancer or chronic pain
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Elective surgery patient American Society of Anesthesiologist PS 1-2 Capable communication in Japanese Willing to attend
Key exclusion criteria	Skin erosion or hypoesthesia in the area of pain pressure measurement Patient started on opioid analgesic within 1 week of the surgery
Target sample size	90

Research contact person
Name of lead principal investigator	Shiroh Isono
Organization	Chiba University Hospital
Division name	Anesthesiology and Palliative Medicine
Address	1-8-1 Inohana Chuo Chiba Japan
TEL	043-226-2303
Email	shirohisono@yahoo.co.jp

Public contact
Name of contact person	Natsuko Nozaki-Taguchi
Organization	Chiba University Hospital
Division name	Anesthesiology and Palliative Medicine
Address	1-8-1 Inohana Chuo Chiba Japan
TEL	043-226-2303
Homepage URL
Email	nnoztag@faculty.chiba-u.jp

Sponsor
Institute	Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Chiba University Hospital
Organization
Division
Category of Funding Organization	Other
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	千葉大学医学部附属病院 (千葉県）

Other administrative information
Date of disclosure of the study information	2013 Year 08 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 07 Day
Anticipated trial start date	2013 Year 08 Month 27 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	2013 Year 08 Month 26 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013352