UMIN-CTR Clinical Trial

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
Email	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
Email	sentoy@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020254