Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of Automatic Implantable Cardioverter Defibrillators (AICDs) and Pacemakers in Pediatric Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a decrease in amount of narcotic medications need and track complications.

Official Title
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Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of AICDs and Pacemakers in Pediatric Patients

Conditions
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Analgesia After Pacemaker, AICDS Implantation Pediatrics

Intervention / Treatment
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* Drug: LA group
* Drug: B Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing implantation or revision of pacemaker or AICD in the pediatric cath lab Exclusion Criteria: parent or patient refusal use of narcotic medications prior to procedure

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 17 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Local Anesthetic (LA Group)<br> | Drug: LA group<br>* In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.<br>|
| Active Comparator: B group<br> | Drug: B Group<br>* In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total narcotic dose in milligram morphine equivalents (MME) needed |  | upto 48 hours after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as measured by the visual analog scale (VAS) pain score | VAS pain scale is a range of scores from 0-100. A higher score indicates greater pain intensity. | up to 1.5 hours post procedure in post anesthesia care unit (PACU) | 
| Number of patients with the incidence of pruritis |  | upto 48 hours after procedure | 
| Number of patients with the incidence of nausea/vomiting |  | upto 48 hours after procedure | 
| Number of patients with respiratory depression |  | upto 48 hours after procedure | 
| Number of patients with local anesthetic toxicity |  | upto 48 hours after procedure | 
| Number of patients with incidence of pneumothorax |  | upto 48 hours after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pacemaker, AICDS, regional anesthesia