UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028759
Receipt number R000032909
Scientific Title A prospective study of chronic postsurgical pain after lung cancer surgery and total knee arthroplasty in Japan
Date of disclosure of the study information 2017/09/01
Last modified on 2020/07/10 12:24:03

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Basic information

Public title

A prospective study of chronic postsurgical pain after lung cancer surgery and total knee arthroplasty in Japan

Acronym

A prospective study of chronic postsurgical pain in Japan

Scientific Title

A prospective study of chronic postsurgical pain after lung cancer surgery and total knee arthroplasty in Japan

Scientific Title:Acronym

A prospective study of chronic postsurgical pain in Japan

Region

Japan


Condition

Condition

Malignant lung tumor
Osteoarthritis
Rheumatoid arthritis

Classification by specialty

Chest surgery Orthopedics Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A prospective multicenter study to confirm the prevalence and risk factors of chronic postsurgical pain after lung cancer surgery and TKA in Japan.

Basic objectives2

Others

Basic objectives -Others

a prospective observational study

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The prevalence of postsurgical pain 3 months and 6 months after surgery

Key secondary outcomes



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 were scheduled lung cancer surgery or TKA during the case registration periods.

Key exclusion criteria

Patients who had other surgeries within 3 months.
Surgery of both sides of lung or knee.
Patients who cannot answer the questions written in Japanese.

Target sample size

1500


Research contact person

Name of lead principal investigator

1st name YOKO
Middle name
Last name Sugiyama

Organization

Gifu university

Division name

Anesthesiology and Pain Medicine

Zip code

501-1194

Address

1-1 Yanagito Gifu city Gifu

TEL

058-230-6404

Email

yoko_sg@gifu-u.ac.jp


Public contact

Name of contact person

1st name YOKO
Middle name
Last name Sugiyama

Organization

Gifu university

Division name

Anesthesiology and Pain Medicine

Zip code

501-1194

Address

1-1 Yanagito Gifu city Gifu

TEL

058-230-6404

Homepage URL


Email

yoko_sg@gifu-u.ac.jp


Sponsor or person

Institute

Gifu university graduate school of medicine Department of Anesthesiology and Pain Medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding
Gifu university

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Shinshu university, Toyama university, Kyoto prefectural university of Medicine, The Jikei university, Juntendo university, Tottori university, Aichi medical university, Osaka university, Yokohama city university, Kawasaki medical school, Wakayama medical university

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gifu university graduate school of medicine IRB

Address

1-1 Yanagido Gifu city, Gifu, JAPAN

Tel

058-230-6059

Email

rinri@gifu-u.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



Other administrative information

Date of disclosure of the study information

2017 Year 09 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

Open public recruiting

Date of protocol fixation

2017 Year 01 Month 04 Day

Date of IRB

2017 Year 08 Month 29 Day

Anticipated trial start date

2017 Year 01 Month 04 Day

Last follow-up date

2020 Year 03 Month 30 Day

Date of closure to data entry

2020 Year 09 Month 30 Day

Date trial data considered complete

2020 Year 09 Month 30 Day

Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information

Collecting data:
Pain intensity (NRS) at rest/with movement 1day, 7days, 1month, 3 and 6 months after surgery. DN4 score, QOL score, HADS score, used analgesics, smoking status, radiation or chemotherapy, surgical procedure, anesthetic methods, demographic data
Primary endpoint: the prevalence of postsurgical pain at 3 and 6months after surgery.
Secondary endpoint: risk factors of chronic postsurgical pain


Management information

Registered date

2017 Year 08 Month 21 Day

Last modified on

2020 Year 07 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032909


Research Plan
Registered date File name
2020/07/10 観察研究_研究計画書final.docx

Research case data specifications
Registered date File name
2020/07/10 データシート 膝関節置換術 8-24-17.docx

Research case data
Registered date File name