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

Phase 4

Completed

• Conditions: Analgesia After Pacemaker; AICDS Implantation Pediatrics
• Interventions: Drug: B Group; Drug: LA group

• Registration Number: NCT04184349
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-03
• Study Start: 2020-10-01
• Primary Completion: 2022-06-09
• Study Completion: 2022-06-09
• Results First Submitted: 2025-03-21
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-02
• Results First Posted: 2025-05-04
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B group	B Group	-
Local Anesthetic (LA Group)	LA group	-

Primary Outcome Measures

Name	Time	Method
Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram	up to 24 hours after procedure

Secondary Outcome Measures

Name	Time	Method
Pain as Measured by the Visual Analog Scale (VAS) Pain Score	up to 24 hours post procedure	VAS pain scale is a range of scores from 0-10. A higher score indicates greater pain intensity.
Pain as Measured by the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale	up to 6 hours post procedure in post anesthesia care unit (PACU)	Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment measures pain with a total score that ranges from 0 to 10; a higher score indicating greater pain.
Number of Patients With the Incidence of Pruritis	up to 48 hours after procedure
Number of Patients With the Incidence of Nausea/Vomiting	up to 48 hours after procedure
Number of Patients With Respiratory Depression	up to 48 hours after procedure
Number of Patients With Local Anesthetic Toxicity	up to 48 hours after procedure
Number of Patients With Incidence of Pneumothorax	up to 48 hours after procedure

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States