UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013075
Receipt number R000015255
Scientific Title Postoperative pain control in Opioid Tolerant patients -Efficacy of the use of iv Oxycodone -
Date of disclosure of the study information 2014/02/05
Last modified on 2018/04/18 09:44:52

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Basic information

Public title

Postoperative pain control in Opioid Tolerant patients -Efficacy of the use of iv Oxycodone -

Acronym

Postoperative pain and Opioid Tolerance

Scientific Title

Postoperative pain control in Opioid Tolerant patients -Efficacy of the use of iv Oxycodone -

Scientific Title:Acronym

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

1st name
Middle name
Last name Nastuko Nozaki-Taguchi

Organization

Chiba University Hospital

Division name

Department of Anesthesiology and Palliative Medicine

Zip code


Address

1-8-1 Inohana Chuo Chiba Japan

TEL

043-226-2303

Email

nnoztag@faculty.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Natsuko Nozaki-Taguchi

Organization

Chiba University Hospital

Division name

Department of Anesthesiology and Palliative Medicine

Zip code


Address

1-8-1 Inohana Chuo Chiba Japan

TEL

043-226-2303

Homepage URL


Email

nnoztag@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



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)



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

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


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

Terminated

Date of protocol fixation

2013 Year 11 Month 08 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015255


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name