UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011580 |
|---|---|
| Receipt number | R000013352 |
| Scientific Title | Opioid Tolerance: Can it be quantitatively assessed? |
| Date of disclosure of the study information | 2013/08/27 |
| Last modified on | 2019/01/28 21:14:19 |
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Basic information
Public title
Opioid Tolerance: Can it be quantitatively assessed?
Acronym
Assessment of Opioid Tolerance
Scientific Title
Opioid Tolerance: Can it be quantitatively assessed?
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shiroh Isono |
Organization
Chiba University Hospital
Division name
Anesthesiology and Palliative Medicine
Zip code
Address
1-8-1 Inohana Chuo Chiba Japan
TEL
043-226-2303
shirohisono@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Natsuko Nozaki-Taguchi |
Organization
Chiba University Hospital
Division name
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 Graduate School of Medicine
Institute
Department
Personal name
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)
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
| 2013 | Year | 08 | Month | 27 | 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
| 2013 | Year | 08 | Month | 07 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013352
