UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042963 |
|---|---|
| Receipt number | R000049047 |
| Scientific Title | Prospective observational study investigating the association between post surgical chronic pain and cardiopulmonary bypass among patients undergoing coronary artery bypass graft. |
| Date of disclosure of the study information | 2021/01/10 |
| Last modified on | 2024/07/16 23:31:35 |
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Basic information
Public title
Prospective observational study investigating the association between post surgical chronic pain and cardiopulmonary bypass among patients undergoing coronary artery bypass graft.
Acronym
Prospective observational study investigating the association between post surgical chronic pain and cardiopulmonary bypass among patients undergoing coronary artery bypass graft.
Scientific Title
Prospective observational study investigating the association between post surgical chronic pain and cardiopulmonary bypass among patients undergoing coronary artery bypass graft.
Scientific Title:Acronym
Prospective observational study investigating the association between post surgical chronic pain and cardiopulmonary bypass among patients undergoing coronary artery bypass graft.
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Surgery in general | Vascular surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between post surgical chronic pain and culdiopulmonary bypass induced inflammation.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between post surgical chronic pain and culdiopulmonary bypass induced inflammation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of Numerical rating scale
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 undergoing bypass surgery for coronary artery disease
Key exclusion criteria
Stroke, porcelain aorta, creatinine>=2.0, severe hiver dysfunction, LVEF<30%, COPD, redo surgery,
Target sample size
167
Research contact person
Name of lead principal investigator
| 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
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
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
Tel
0661701070
k.minami@ncvc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R19031
Org. issuing International ID_1
National cerebral and cardiovascular center
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 | 01 | Month | 10 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00540-023-03202-7
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00540-023-03202-7
Number of participants that the trial has enrolled
104
Results
Ordinal logistic regression showed that the NRS response for current pain (odds ratio [OR] 2.34; 95% CI 1.12-4.92; P = 0.024) and the NRS response for peak pain in the last 4 weeks (OR 2.71; 95% CI 1.35-5.42; P = 0.005) were significantly higher in patients who underwent on-pump CABG surgery than in those who underwent off-pump CABG.
Logistic regression showed that on-pump CABG surgery was an independent predictor of CPSP (OR 2.59; 95% CI 1.06-6.31; P = 0.036).
Results date posted
| 2024 | Year | 07 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The questionnaire was answered at a median of 16.9 years postoperatively. Among 167 participants, 32 patients were lost to follow-up. Of the 135 patients contacted, 104 answered the questionnaire (77.0%).
Participant flow
This prospective, observational study was performed on a cohort from a randomized trial (on-pump CABG: 81 patients, off-pump CABG: 86 patients). A questionnaire about the severity of surgical wound pain that evaluated pain with the numerical rating scale (NRS) was filled out by the patients.
Adverse events
None.
Outcome measures
The main outcomes were the severity of CPSP as evaluated using the NRS and the prevalence of CPSP. CPSP was defined as pain with an NRS score > 0. Differences in severity between groups were analyzed using multivariate ordinal logistic regression models adjusted for age and sex, and differences in prevalence between groups were analyzed using multivariate logistic regression models adjusted for age and sex.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigate the difference in NRS score between on pump CABG versus off pump CABG
Management information
Registered date
| 2021 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049047
