UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044302 |
|---|---|
| Receipt number | R000042857 |
| Scientific Title | Comparison of Continuous Thoracic Epidural and Paravertebral Blocks for postoperative Analgesia and Complications after Minimally Invasive Cardiac Surgery |
| Date of disclosure of the study information | 2021/05/24 |
| Last modified on | 2022/05/02 14:30:39 |
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Basic information
Public title
Comparison of Continuous Thoracic Epidural and Paravertebral Blocks for postoperative Analgesia and Complications after Minimally Invasive Cardiac Surgery
Acronym
Comparison of Continuous Thoracic Epidural and Paravertebral Blocks for postoperative Analgesia and Complications after Minimally Invasive Cardiac Surgery
Scientific Title
Comparison of Continuous Thoracic Epidural and Paravertebral Blocks for postoperative Analgesia and Complications after Minimally Invasive Cardiac Surgery
Scientific Title:Acronym
Comparison of Continuous Thoracic Epidural and Paravertebral Blocks for postoperative Analgesia and Complications after Minimally Invasive Cardiac Surgery
Region
| Japan |
Condition
Condition
mitral regulation
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare continuous thoracic epidural analgesia and paravertebral block for postoperative analgesia in patients undergoing minimally invasive cardiac surgery for quality of analgesia, complications.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The means of postoperative NRS at 0 hours (endotracheal extubation), 2hours and 6hours.
Key secondary outcomes
NRS at 12hours, 24hours,48hours after extubation.
NRS at the first time after discharged hospital
Hemodynamics during operation
Postoperative course: intubation time, ICU stay, hospital stay
postoperative complications: re-intubation, Non-invasive positive pressure ventilation, pulmonary complication, arrhythmia(including new onset of atrial fibrillation or flutter), postoperative nausea and vomitting
Patient satisfaction
Side effects of epidural or paravertebral catheter insertion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
epidural block group:
epidural block catheter insertion the day before operation.5ml administration of 0.25% revobupivacane between anesthetic induction and operation starts.
3ml per hour continuous infusion of 0.2% revobupivacaine when cardio-pulmonary bypass starts.
The catheter is removed 48hours after extubation.
Interventions/Control_2
paravertebral block group:
paravertebral block catheter insertion the day before operation.10ml administration of 0.25% revobupivacane between anesthetic induction and operation starts.
6ml per hour continuous infusion of 0.2% revobupivacaine when cardio-pulmonary bypass starts.
The catheter is removed 48hours after extubation.
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
Adults elective cardiac surgical patients undergoing minimally invasive cardiac surgery with lateral thoracotomy under cardiopulmonary bypass
Key exclusion criteria
under 18 years
re-operation
hepatic disorder
renal disorder
low platelet
coagulation disorder
intake of anticoagulant or antiplatelet drugs
chest deformity
mental illness
malignant disease
regular use of analgesics
use of steroids
collagesn disease
history of heparin-indused thrombocytopenia
allergic to heparin
allergic to local anesthetic
local infection at puncture site
disagree to this study
other reasons considered by surgeons or anesthesiologist
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Chiho |
| Middle name | |
| Last name | Shimizu |
Organization
Osaka Police Hospital
Division name
Anesthesiology
Zip code
5430035
Address
Kitayama-cho 10-31, Tennoji, Osaka
TEL
0667716051
chichihoho1008@gmail.com
Public contact
Name of contact person
| 1st name | Chiho |
| Middle name | |
| Last name | Shimizu |
Organization
Osaka Police Hospital
Division name
Anesthesiology
Zip code
5430035
Address
Kitayama-cho 10-31, Tennoji, Osaka
TEL
0667715051
Homepage URL
chichihoho1008@gmail.com
Sponsor or person
Institute
Osaka Police Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka police hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Police Hospital
Address
Kitayama-cho 10-31, Tennoji, Osaka
Tel
5430035
chichihoho1008@gmail.com
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 | 05 | Month | 24 | 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
| 2019 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 24 | Day |
Last modified on
| 2022 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042857
