UMIN-CTR Clinical Trial

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
Email	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
Email	chichihoho1008@gmail.com

Sponsor
Institute	Osaka Police Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042857