Analgesic Efficacy of Ultrasound Guided Bilateral Erector Spinae Plane Block in Pediatric.

Cairo University (CU)

Status

Completed

Conditions

Anesthesia, Local

Analgesia

Treatments

Procedure: bilateral erector spinae block

Study type

Interventional

Funder types

Other

Identifiers

NCT04452656

N159-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

98 patients

Sex

All

Ages

6 months to 7 years old

Volunteers

No Healthy Volunteers

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).