UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016118 |
|---|---|
| Receipt number | R000017847 |
| Scientific Title | Utility of acetoaminophen for postoperative pain management after TUR-BT |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2015/07/31 11:35:13 |
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Basic information
Public title
Utility of acetoaminophen for postoperative pain management after TUR-BT
Acronym
Acetoaminophen for postoperative pain management after TUR-BT
Scientific Title
Utility of acetoaminophen for postoperative pain management after TUR-BT
Scientific Title:Acronym
Acetoaminophen for postoperative pain management after TUR-BT
Region
| Japan |
Condition
Condition
Patient who undergo TUR-BT
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy of acetoaminophen for TUR-BT pain management
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pain nausea
Key secondary outcomes
delirium, urine discomfort
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administer Acetoaminophen
Interventions/Control_2
Do not administer Acetoaminophen
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient who undergo TURBT
Key exclusion criteria
Patient who take analgesics
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyasu Komasawa |
Organization
Department of Anesthesiology
Division name
Anesthesiology
Zip code
Address
2-7Daigakumachi Takatsuki
TEL
072-684-6361
ane078@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Komasawa Nobuyasu |
Organization
Osaka MEdical College
Division name
Anesthesiology
Zip code
Address
2-7 Daigakumachi Takatsuki
TEL
(0726-84-6361)
Homepage URL
ane078@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | 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
In both general and spinal anesthesia, the stimulating pain or uncomfortable urinary symptoms.
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
| 2014 | Year | 10 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The number of additional acetoaminophen postoperative administration also did not differ.
Management information
Registered date
| 2015 | Year | 01 | Month | 05 | Day |
Last modified on
| 2015 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017847
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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