Completed

NCT Number: NCT04184349

Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of Automatic Implantable Cardioverter Defibrillators (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.

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Key information

Conditions

Analgesia After Pacemaker AICDS Implantation Pediatrics

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LA group

Drug

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

B Group

Drug

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

Primary outcomes

Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram

Time frame: From 24 hours after procedure to 48 hours after procedure
Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram

Time frame: up to 24 hours after procedure

Secondary outcomes

Pain as Measured by the Visual Analog Scale (VAS) Pain Score

Time frame: up to 1.5 hours post procedure in post anesthesia care unit (PACU)

VAS pain scale is a range of scores from 0-100. A higher score indicates greater pain intensity.
Pain as Measured by the Visual Analog Scale (VAS) Pain Score

Time frame: 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

Time frame: 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

Time frame: up to 48 hours after procedure
Number of Patients With the Incidence of Nausea/Vomiting

Time frame: up to 48 hours after procedure
Number of Patients With Respiratory Depression

Time frame: up to 48 hours after procedure
Number of Patients With Local Anesthetic Toxicity

Time frame: up to 48 hours after procedure
Number of Patients With Incidence of Pneumothorax

Time frame: up to 48 hours after procedure

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Dec 3, 2019
Registry last updated: May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.