NCT04452656

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

Analgesic Efficacy of Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Cardiac Surgeries. a Randomized Controlled Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 6 Months – 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia, Local
• Analgesia

Interventions

Type	Name	Description
PROCEDURE	bilateral erector spinae block	An ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process. Three muscles; trapezius , rhomboids major , and erector spinae will be identified superior to the hyperechoic transverse process. Using in-plane approach a 25 G needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle. Correct needle tip location will be confirmed by injecting 3 mL of saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process.. 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) will be injected and visualizing the linear LA spread in the fascial plane between the erector spinae muscle andthe transverse process12.

Timeline

• Start date: 2020-07-20
• Primary completion: 2021-08-05
• Completion: 2021-08-15
• First posted: 2020-06-30
• Last updated: 2021-12-21

Locations

1 site across 1 country: Egypt