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
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
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
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
