UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017477 |
|---|---|
| Receipt number | R000020254 |
| Scientific Title | The influence of the revised criteria for postanesthesia care unit discharge on postoperative pain managements |
| Date of disclosure of the study information | 2015/05/09 |
| Last modified on | 2021/05/20 14:14:08 |
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Basic information
Public title
The influence of the revised criteria for postanesthesia care unit discharge on postoperative pain managements
Acronym
The influence of the revised criteria for postanesthesia care unit discharge on postoperative pain managements
Scientific Title
The influence of the revised criteria for postanesthesia care unit discharge on postoperative pain managements
Scientific Title:Acronym
The influence of the revised criteria for postanesthesia care unit discharge on postoperative pain managements
Region
| Japan |
Condition
Condition
postoperative patients
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is planed to collect data about postoperative pain before and after the criteria is revised for postanesthesia care unit discharge to make it the basic data to consider the measure to improve the quality of postoperative pain management.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate whether quality of postoperative pain managements are improved and postoperative safety is kept after pain scores are added to discharge criteria for the PACU.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Adding pain scores to the critesia for PACU discharge.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Every postoperative patient who have undergone a surgical procedure under anesthetic management by a anesthesiologist
Key exclusion criteria
pediatric patients under 18 years-old, patients needed intensive care in the Intensive Care Unit, patients underwent electricconvulsive therapy
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | SENTO |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
467-8601
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN
TEL
052-851-5511
sentoy@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | SENTO |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
467-8601
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN
TEL
052-851-5511
Homepage URL
sentoy@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
none
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
Nagoya City University Hospital
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN
Tel
052-851-5511
sentoy@med.nagoya-cu.ac.jp
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
名古屋市立大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 09 | 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
| 2015 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 09 | Day |
Last modified on
| 2021 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020254
