Analgesic Efficacy of Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Cardiac Surgeries. a Randomized Controlled Study.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Anesthesia, Local
- Sponsor
- Cairo University
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- The total dose of intraoperative fentanyl boluses in microgram.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This randomized, double-blinded, study aims to compare the efficacy of analgesia and any side effects of U/S guided bilateral Erector SpinaePlane block versus non-block t paediatric patients undergoing corrective cardiac surgeries.
Detailed Description
Our study will be designed to estimate and compare the analgesic effect of single shotbilatral erector spinae plane block in pediatric patients undergoing corrective cardiac surgeries versus non-block as the control group. Our primary outcome will be the total dose of intraoperative fentanyl boluses. Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A medical personnel not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anesthesiologist who is expert in doing the ESP block in patients included within the block group. The anesthesia team who managed the patients intraoperatively did not share in recording data for the research. However, another physcian will be responsible for recording the intraoperative data.
Investigators
AHMED ALI GADO
Director
Cairo University
Eligibility Criteria
Inclusion Criteria
- •Age:6 months-7 years.
- •ASA, American Society of Anesthesiology, II and III .
- •Patients undergoing cardiac surgeries with midline sternotomy incision.
Exclusion Criteria
- •Patients whose parents or legal guardians refusing to participate.
- •Preoperative mechanical ventilation.
- •Preoperative inotropic drug infusion.
- •Known or suspected coagulopathy.
- •Any congenital anomalies of the sacrum/the vertebral column or any infection at the site of injection.
- •Known or suspected allergy to any of the studied drugs.
- •Elevated liver enzymes more than the normal values.
- •Renal function impairment (Creatinine value more than 1.2 mg/dl or BUN more than 20mg/dl).
Outcomes
Primary Outcomes
The total dose of intraoperative fentanyl boluses in microgram.
Time Frame: 3 months
The total dose of intraoperative fentanyl boluses in microgram
Secondary Outcomes
- Total consumption of morphine during the first 24 hours postoperatively.(3 monts)
- Pain assessment at postoperatively by FLACC score(3 months)
- extubation time(3 months)