UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037879 |
|---|---|
| Receipt number | R000043089 |
| Scientific Title | Prevalence of post thoracotomy pain syndrome (PTPS). Its association between preoperative anxiety and acute postoperative pain. |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2023/08/23 16:28:09 |
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Basic information
Public title
Prevalence of post thoracotomy pain syndrome (PTPS). Its association between preoperative anxiety and acute postoperative pain.
Acronym
Analysis of the analysis associated with PTPS
Scientific Title
Prevalence of post thoracotomy pain syndrome (PTPS). Its association between preoperative anxiety and acute postoperative pain.
Scientific Title:Acronym
Analysis of the analysis associated with PTPS
Region
| Japan |
Condition
Condition
post thoracotomy pain syndrome
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will investigate prevalence of PTPS in Japan.
We will also analyze association between preoperative anxiety or neuropathic pain in acute postoperative period and PTPS.
Basic objectives2
Others
Basic objectives -Others
Prevalence rate of the disease
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of PTPS 3months after the surgery
Association between preoperative anxiety or neuropathic pain in acute postoperative period and PTPS.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient who receive malignant lung or mediastinum surgery in Kyoto prefectural university of medicine hospital from the date of IRB approve to 31 Dec 2022.
Patient with informed consent with written document.
Key exclusion criteria
history of chest surgery
history of peripheral neuropathy
patient unable to complete questionnaire
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | fumimasa |
| Middle name | |
| Last name | amaya |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of pain management and palliative care medicine
Zip code
602-8566
Address
Kajii-cho 465 Kamigyo-ku Kyoto
TEL
075-251-5177
ama@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | fumimasa |
| Middle name | |
| Last name | amaya |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of pain management and palliative care medicine
Zip code
602-8566
Address
Kajii-cho 465 Kamigyo-ku Kyoto
TEL
075-251-5177
Homepage URL
ama@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Department of pain management and palliative care medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
Kajiicho 465 Kamigyo-Ku Kyoto
Tel
075-251-5177
ama@koto.kpu-m.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
| 2019 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prevalence of chronic postoperative pain and quality of life 3 months after the surgery are assessed by using questionnaire.
Management information
Registered date
| 2019 | Year | 09 | Month | 01 | Day |
Last modified on
| 2023 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043089
