PECs Block for Pacemaker Insertion in Children

Study Overview
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Brief Summary
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Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral pacemaker insertion in Children: Randomized Controlled Trial

Detailed Description
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BACKGROUND Pectoral nerve blocks (PECs) can reduce intraprocedural anesthetic requirements and postoperative pain. Little is known about the utility of PECs in reducing pain and narcotic use after pacemaker (PM)placement in children. OBJECTIVE The purpose of this study was to determine whether PECs can decrease postoperative pain and opioid use after PM placement in children. METHODS A single-center controlled trial of pediatric patients undergoing transvenous PM placement between 2020 and 2021 will be performed. Demographics, procedural variables, postoperative pain, and postoperative opioid usage will be compared between patients who undergone PECs and those who undergone conventional anesthetic (Control).

Official Title
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Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral Pacemaker Insertion in Children: Randomized Controlled Trial

Conditions
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Complete Heart Block

Intervention / Treatment
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* Drug: paracetamol
* Procedure: modifiedPECs block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: congenital or post-operative heart block. Exclusion Criteria: ⦁ Redo patient History of allergic reactions to local anesthetics. Bleeding disorders with International Normalization Ratio( INR) > 1.5 and/or platelets < 50 000. Rash or signs of infection at the injection site. Emergency procedure

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 9 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
Interventional Model Description: The patient will be randomly assigned to two equal groups. conventional control group(C) (n=20) where20 children will receive IV paracetamol 20 mg / kg . and Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block .
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>conventional control group(C) (n=20) where20 children will receive IV paracetamol 20 mg / kg and atracurium top ups at a dose of 0.1mg/kg. every 30 minutes. | Drug: paracetamol<br>* iv post operative analgesia<br>* Other names: perfalgan;|
| Active Comparator: PECs<br>Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block and atracurium top ups upon request. | Procedure: modifiedPECs block<br>* sonar guided pectoral nerve block<br>* Other names: PECs 2 block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale. | pain score | immediate, 6,12 ,18 and 24 hours after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total consumption of opioids. | morphine dose | immediate, 6,12 ,18 and 24 hours after intervention |