UMIN-CTR Clinical Trial

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
Email	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
Email	k.minami@ncvc.go.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052309