Randomized Clinical Trial to Evaluate the Superiority on the Decrease the Consumption of Fentanyl the First 48 Hours of Bilateral Serratus Intercostal Plane Block in Myocardial Revascularization Surgery by Sternotomy.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Fentanyl Consume
Study Overview
Brief Summary
Two-parallel arm, double-blind, individually randomized controlled trial.
Primary endpoint:
Fentanyl consumption in the first 48 postoperative hours.
Secondary endpoints:
Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV), sedation, Hemothorax, seizures, arrythmias
Detailed Description
Trial design: Two-parallel arm, double-blind, individually randomized controlled trial.
Primary endpoint:
Fentanyl consumption in the first 48 postoperative hours.
Secondary endpoints:
Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV), sedation, Hemothorax, seizures, arrythmias
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Participant: The Patients will not know about intervention group they will be. Care Provider : The medical, nursing and pain clinical will not know the group to which the patient belongs Outcomes Assessor: during the analysis the staff will not know which group the patient belong
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient between 18 years to 80 years
- •Patient to myocardial revascularization by sternotomy
Exclusion Criteria
- •Patient for combined surgery ( myocardial revascularization by sternotomy plus valve or maze)
- •Emergency surgery
- •Ejection Fraction less than 35%
- •Allergy to the local anesthesics.
- •Allergy to opioids
- •Patient in who will be technically impossible the application of the blockade
Outcomes
Primary Outcomes
Fentanyl Consume
Time Frame: 48 hours
Microgrames of Fentanyl that patient consume during the first 48 hours in the postoperative
Secondary Outcomes
- hemothorax(24 hours)
- Nausea and vomiting(48 hours.)
- Pain In Rest and in motion(48 hours)
- Sedation(48 hours.)
- seizures(1 hour after block)
- Arrhythmias(1 hour after block)