UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021147
Receipt number R000024396
Scientific Title Prevalence of subacute and persistent post-operative pain: a multicenter observational study in Japan
Date of disclosure of the study information 2016/02/22
Last modified on 2018/08/24 12:37:42

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Basic information

Public title

Prevalence of subacute and persistent post-operative pain: a multicenter observational study in Japan

Acronym

Prevalence of persistent postoperative pain in Japan

Scientific Title

Prevalence of subacute and persistent post-operative pain: a multicenter observational study in Japan

Scientific Title:Acronym

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

1st name
Middle name
Last name Yoko Sugiyama

Organization

Gifu University Graduate School of Medicine

Division name

Anesthesiology and Pain Medicine

Zip code


Address

1-1 Yanagido Gifu city

TEL

81-58-230--6404

Email

yoko_sg@gifu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoko Sugiyama

Organization

Gifu University Graduate School of Medicine

Division name

Anesthesiology and Pain Medicine

Zip code


Address

1-1 Yanagido Gifu city

TEL

81-58-230--6404

Homepage URL


Email

yoko_sg@gifu-u.ac.


Sponsor or person

Institute

Japanese Study Group of Subacute Postoperative Pain

Institute

Department

Personal name



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)



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

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


Related information

URL releasing protocol


Publication of results

Published


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 11 Month 11 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024396


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name