UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prevalence of subacute and persistent post-operative pain: a multicenter observational study in Japan
Title of the study (Brief title)	Prevalence of persistent postoperative pain in Japan
Region	Japan

Condition
Condition	lung cancer osteoarthraitis of the knee
Classification by specialty	Chest surgery Orthopedics Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the prevalence of subacute and persistent postoperative pain among Japanese population
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	prevalence of pain 3 and 6 months after surgery
Key secondary outcomes	use of analgesics 3 and 6 months after surgery

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent lung cancer surgery and total knee arthroplasty
Key exclusion criteria	re-operation within 6 months bilateral surgery
Target sample size	1000

Research contact person
Name of lead principal investigator	Yoko Sugiyama
Organization	Gifu University Graduate School of Medicine
Division name	Anesthesiology and Pain Medicine
Address	1-1 Yanagido Gifu city
TEL	81-58-230--6404
Email	yoko_sg@gifu-u.ac.jp

Public contact
Name of contact person	Yoko Sugiyama
Organization	Gifu University Graduate School of Medicine
Division name	Anesthesiology and Pain Medicine
Address	1-1 Yanagido Gifu city
TEL	81-58-230--6404
Homepage URL
Email	yoko_sg@gifu-u.ac.

Sponsor
Institute	Japanese Study Group of Subacute Postoperative Pain
Institute
Department

Funding Source
Organization	Japanese Study Group of Subacute Postoperative Pain
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kyoto prefecturaluniversity Jikei university Juntendo university Shinshu university Tottori university Toyama university
Name of secondary funｄer(s)

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	岐阜大学病院（岐阜県）、京都府立医科大学病院（京都府）、慈恵医科大学病院（東京都）、順天堂大学病院（東京都）、信州大学病院（長野県）、鳥取大学病院（鳥取県）、富山大学（富山県）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 11 Day
Anticipated trial start date	2015 Year 11 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 08 Month 24 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Retrospective chart review for the patients who underwent lung cancer surgery and TKA in 2013

Management information
Registered date	2016 Year 02 Month 22 Day
Last modified on	2018 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024396