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

NCT04184349 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-05-04

Study results available
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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.

Conditions

  • Analgesia After Pacemaker
  • AICDS Implantation Pediatrics

Interventions

DRUG

LA group

In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.

DRUG

B Group

In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Olga Pewelek, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-06-09
Completion
2022-06-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04184349 on ClinicalTrials.gov