UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045817 |
|---|---|
| Receipt number | R000052309 |
| Scientific Title | Observational study investigating the association between the intensity of post-thoracotomy pain and the elapsed time after surgery |
| Date of disclosure of the study information | 2021/10/21 |
| Last modified on | 2022/05/30 11:32:34 |
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Basic information
Public title
Observational study investigating the association between the intensity of post-thoracotomy pain and the elapsed time after surgery
Acronym
Observational study investigating the association between the intensity of post-thoracotomy pain and the elapsed time after surgery
Scientific Title
Observational study investigating the association between the intensity of post-thoracotomy pain and the elapsed time after surgery
Scientific Title:Acronym
Observational study investigating the association between the intensity of post-thoracotomy pain and the elapsed time after surgery
Region
| Japan |
Condition
Condition
Patients who underwent thoracotomy
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We hypothesized that CPSP intensity would continue to decrease until a certain time. To test this hypothesis, we conducted a prospective observational study to clarify the nonlinear association between the elapsed time after surgery and the intensity of post-thoracotomy pain.
Basic objectives2
Others
Basic objectives -Others
We hypothesized that CPSP intensity would continue to decrease until a certain time. To test this hypothesis, we conducted a prospective observational study to clarify the nonlinear association between the elapsed time after surgery and the intensity of post-thoracotomy pain.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The severity of CPSP evaluated using NRS
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who underwent thoracotomy
Key exclusion criteria
none
Target sample size
236
Research contact person
Name of lead principal investigator
| 1st name | Kimito |
| Middle name | Minami |
| Last name | Minami |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Surgical Intensive Care
Zip code
564-8565
Address
6-1 Kishibeshinmachi, Suita, Osaka
TEL
0661701070
k.minami@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Kimito |
| Middle name | |
| Last name | Minami |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of surgical intensive care
Zip code
564-8565
Address
6-1 Kishibeshinmachi, Suita, Osaka
TEL
0661701070
Homepage URL
k.minami@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
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
National Cerebral and Cardiovascular Center
Address
6-1 Kishibeshinmachi, Suita, Osaka
Tel
0661701070
k.minami@ncvc.go.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
| 2021 | Year | 10 | Month | 21 | 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
236
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 05 | Month | 10 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the nonlinear association between elapsed time after surgery and the intensity of post-thoracotomy pain, multivariable ordinal logistic regression with restricted cubic splines was used with the following factors as independent variables: age, gender, and operative time. Restricted cubic spline analysis is a way to test if the relationships between outcomes and explanatory variables are nonlinear. The three knots of restricted cubic splines were located at the 10th, 50th, and 90th percentiles.
Management information
Registered date
| 2021 | Year | 10 | Month | 21 | Day |
Last modified on
| 2022 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052309
