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

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia After Pacemaker; AICDS Implantation Pediatrics
• Intervention / Treatment: Drug: LA group; Drug: B Group

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Local Anesthetic (LA Group)	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.
Active Comparator: B group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram	From 24 hours after procedure to 48 hours after procedure
Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram	up to 24 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)
Pain as Measured by the Visual Analog Scale (VAS) Pain Score	VAS pain scale is a range of scores from 0-10. A higher score indicates greater pain intensity.	up to 24 hours post procedure
Pain as Measured by the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale	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.	up to 6 hours post procedure in post anesthesia care unit (PACU)
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Olga Pewelek, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 9, 2022
• Study Completion (Actual): June 9, 2022

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: regional anesthesia; pacemaker; AICDS
• Other Study ID Numbers: HSC-MS-19-0760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No