UMIN-CTR Clinical Trial

Basic information
Public title	investigation on an incidence of post surgical persistent pain
Acronym	investigation on an incidence of post surgical persistent pain
Scientific Title	investigation on an incidence of post surgical persistent pain
Scientific Title:Acronym	investigation on an incidence of post surgical persistent pain
Region	Japan Australia

Condition
Condition	All patients enrolled in 'Impact on ADL and cognitive function receiving operation'
Classification by specialty	Anesthesiology Operative medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to investigate the proportion of the postoperative persistent pain and the factors affecting them
Basic objectives2	Others
Basic objectives -Others	Not Applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of postoperative pain
Key secondary outcomes	Variables that affect primary outcome

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	patients will be asked to answer a questionnaire about their postoperative pain and it's nature at 3month and 1year after the surgery
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing surgery patients able to answer questionnaire in Japanese
Key exclusion criteria	Patients requiring reoperation
Target sample size	10000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kawaguchi Masahiko
Organization	Nara Medical University
Division name	Department of Anesthesiology
Zip code
Address	840 Shijo-cho, Kashihara, Nara, Japan
TEL	+81-(0)744-22-3051
Email	drjkawa@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Yusuke Naito
Organization	Nara Medical University
Division name	Department of Anesthesiology
Zip code
Address	840 Shijo-cho, Kashihara, Nara, Japan
TEL	+81-(0)744-22-3051
Homepage URL
Email	schneider.yusuke@gmail.com

Sponsor
Institute	Department of Anesthesiology, Nara Medical University
Institute
Department

Funding Source
Organization	Self Funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	奈良県立医科大学附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 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	Preinitiation
Date of protocol fixation	2016 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 01 Month 15 Day
Date trial data considered complete	2022 Year 01 Month 31 Day
Date analysis concluded	2022 Year 06 Month 30 Day

Other
Other related information	Patients will be asked if they have persistent postoperative pain 3month after surgery. The patients will be divided into two groups whether they have persistent postoperative pain or not and will be analysed.

Management information
Registered date	2016 Year 03 Month 31 Day
Last modified on	2016 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024498

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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