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

Not Applicable

Completed

• Conditions: Anesthesia, Local; Analgesia
• Interventions: Procedure: bilateral erector spinae block

• Registration Number: NCT04452656
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-06-30
• Study Start: 2020-07-20
• Primary Completion: 2021-08-05
• Study Completion: 2021-08-15
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-04
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bilateral erector spinae plane block	bilateral erector spinae block	The patient WILL receive bilateral erector spinae plane block.

Primary Outcome Measures

Name	Time	Method
The total dose of intraoperative fentanyl boluses in microgram.	3 months	The total dose of intraoperative fentanyl boluses in microgram

Secondary Outcome Measures

Name	Time	Method
Total consumption of morphine during the first 24 hours postoperatively.	3 monts	Total consumption of morphine during the first 24 hours postoperatively
Pain assessment at postoperatively by FLACC score	3 months	Pain assessment postoperatively by FLACC score
extubation time	3 months	time from finishing skin incision suturing and cessation of anesthesia to successful removal of endotracheal tube.

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt