Status:
COMPLETED
Nociception-directed Erector Muscle Spinae Plane Block in Open Heart Surgery
Lead Sponsor:
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Conditions:
Regional Anesthesia
Heart Surgery
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
With the advent of ultrasound (US) guidance, use of regional anaesthesia (RA) is poised to grow and evolve. Recently, cardiac surgery has benefited from newer US guided interfascial techniques as they...
Detailed Description
DETAILED DESCRIPTION OF STUDY A. Ethics Local Ethics Committee approval and Informed Consent from patient or next-of-kin are obtained prior to study enrolment. B. Study enrolment Eighty adult pati...
Eligibility Criteria
Inclusion
- Informed Consent.
- Elective heart surgery with sternotomy and bypass.
- Hemodynamic stability prior to induction (no chest pain, SAP \> 100 mmHg, MAP ≥ 60 mmHg, 50 \< HR \< 100 bpm).
- Sinus rhythm.
Exclusion
- Known allergy to any of the medications used in the study.
- BMI \> 35.
- Patient refusal to participate in the study.
- Coagulopathy (INR \> 1.5, APTT \> 45, Fibrinogen \< 150 mg/dl).
- Non-elective/emergent and/or redo surgery.
- ASA ≥ 4.
- Any preoperative hemodynamic support (mechanical or pharmaceutical).
- Severe LV dysfunction (LVEF ≤ 30%).
- Severe RV dysfunction or PHT (RVFAC ≤ 25%).
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04338984
Start Date
December 1 2019
End Date
May 31 2021
Last Update
August 12 2022
Active Locations (1)
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1
Prof Dr CC Iliescu Institute for Emergency Cardiovascular Diseases
Bucharest, Romania, 022328