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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042857


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name