UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028759
Receipt No. 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 2017/08/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Yoko Sugiyama, Hiroki Iida
Organization Gifu university
Division name Anesthesiology and Pain Medicine
Zip code
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
Middle name
Last name Yoko Sugiyama
Organization Gifu university
Division name Anesthesiology and Pain Medicine
Zip code
Address 1-1 Yanagito Gifu city Gifu
TEL 058-230-6404
Homepage URL
Email yoko_sg@gifu-u.ac.jp

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

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
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

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
Anticipated trial start date
2017 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2017 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032909

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.