Status:
TERMINATED
Benefit of Peri-operative Bilateral ESP Catheters for Enhanced Recovery for Cardiac Surgery (ERCS)
Lead Sponsor:
Vinmec Healthcare System
Conditions:
Open Heart Surgery
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
To demonstrate if the addition of peri-operative regional analgesia by Bilateral ESP catheters improves the enhanced recovery program after open heart surgeries for the duration of hospitalisation, qu...
Detailed Description
I. CONSULTING PHASE: 1 WEEK BEFORE SURGERY 1. Preoperative information, education and counselling: patient and families receive dedicated preoperative counselling including information packets. 2. Pr...
Eligibility Criteria
Inclusion
- Open heart surgeries: Valvulopathies ( 1-2 valves, repair or replacement)
- Congenital heart disease (Risk Adjustment in Congenital Heart Surgery Category 1-2 ( VSD, ASD, T4F)
- NYHA II,
- Fraction ejection \> 50%,
- PAPS \< 50 mmHg.
- Male
- Female
- Age from 18-60 years old.
- Consent participation
Exclusion
- Refusal participation.
- Allergy to LA
- Severe thoracic Scoliosis
- Valvulopathies association with :
- CABG
- BENTALL procedure
- Deficit mental
- Alcoholics,
- Heroine addicted
- Insufficient renal
- liver failure
- Endocarditis \<1 year
- Stroke \<3 months
- MI \<3 months
- Bloc AV II or III with Pacemaker permanent
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04506762
Start Date
November 1 2020
End Date
August 14 2023
Last Update
August 18 2023
Active Locations (1)
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1
VinMec INternational hopspital
Hanoi, Vietnam