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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthesia, Local, Analgesia

Intervention / Treatment
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* Procedure: bilateral erector spinae block


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bilateral erector spinae plane block<br>The patient WILL receive bilateral erector spinae plane block. | Procedure: bilateral erector spinae block<br>* 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.<br>|
| No Intervention: NO BLOCK<br>The patient will not receive Erector spinae plane block | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total dose of intraoperative fentanyl boluses in microgram. | The total dose of intraoperative fentanyl boluses in microgram | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erector spinae plane block, Pediatric, sternotomy