UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Postoperative pain control in Opioid Tolerant patients -Efficacy of the use of iv Oxycodone -
Title of the study (Brief title)	Postoperative pain and Opioid Tolerance
Region	Japan

Condition
Condition	Postoperative cancer pain
Classification by specialty	Surgery in general Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Improved efficacy in opioid tolerant cancer surgical pain
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Effective pain control (Numerical Rating Scale at rest <5) with calculated opioid dose.
Key secondary outcomes	1.Safety determined from the frequency of side-effects (respiratory depression, nausea, itching) in need of treatment. 2. Use of pain and respiratory threshold measurement in the calculation of opioid dosage. 3.Determination of Oxycodone po to iv ratio.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Cancer patient for surgery treatment 2) Pain controlled by oxycodone or fentanyl for over 1 month 3) Age over 20 yrs old 4) ASA Physical status 1 or 2 5) Not pregnant 6) Informed consent by his/her own will
Key exclusion criteria	1) Opioid treatment for non-cancer pain 2) Hepatic failure (AST or ALT >300IU) 3) Renal failure (BUN>50 Cre>3.0) 4) Pregnant or breast feeding patient 5) Not applicable determined by the Dr responsible for the trial.
Target sample size	20

Research contact person
Name of lead principal investigator	Nastuko Nozaki-Taguchi
Organization	Chiba University Hospital
Division name	Department of Anesthesiology and Palliative Medicine
Address	1-8-1 Inohana Chuo Chiba Japan
TEL	043-226-2303
Email	nnoztag@faculty.chiba-u.jp

Public contact
Name of contact person	Natsuko Nozaki-Taguchi
Organization	Chiba University Hospital
Division name	Department of 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 Hospital
Institute
Department

Funding Source
Organization	Chiba University Hospital
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 02 Month 05 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 11 Month 08 Day
Anticipated trial start date	2014 Year 02 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2018 Year 04 Month 18 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Severity of post-operative pain No of additive analgesia Presence of side-effect (nausea, respiratory depression, pruritus, sedation score)

Management information
Registered date	2014 Year 02 Month 05 Day
Last modified on	2018 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015255