NCT04184349

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

Completed Phase 4 Results posted Last updated 4 May 2025

What this trial tests

Phase 4 trial testing LA group in Analgesia After Pacemaker in 19 participants. Completed in 9 June 2022.

Timeline

1 October 2020

Primary endpoint
9 June 2022

9 June 2022

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	1 October 2020
Primary completion	9 June 2022
Estimated completion	9 June 2022
Sites	1 location across United States

Drugs / interventions tested

• LA group — full drug profile →
• B Group

Conditions studied

• Analgesia After Pacemaker — all drugs for Analgesia After Pacemaker →
• AICDS Implantation Pediatrics — all drugs for AICDS Implantation Pediatrics →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

Adults 0 to 17, any sex, with Analgesia After Pacemaker or AICDS Implantation Pediatrics. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram Primary · From 24 hours after procedure to 48 hours after procedure

Group	Value	95% CI
Local Anesthetic (LA Group)	0.035	± 0.082
B Group	0.008	± 0.026

Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram Primary · up to 24 hours after procedure

Group	Value	95% CI
Local Anesthetic (LA Group)	0.021	± 0.044
B Group	0.008	± 0.026

Pain as Measured by the Visual Analog Scale (VAS) Pain Score Secondary · up to 24 hours post procedure

VAS pain scale is a range of scores from 0-10. A higher score indicates greater pain intensity.

Group	Value	95% CI
Local Anesthetic (LA Group)	1.33	± 2.23
B Group	3.44	± 3.46

Pain as Measured by the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale Secondary · 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.

Group	Value	95% CI
Local Anesthetic (LA Group)	1.28	± 2.36
B Group	1.62	± 2.92

Number of Patients With the Incidence of Pruritis Secondary · up to 48 hours after procedure

Group	Value	95% CI
Local Anesthetic (LA Group)	0
B Group	0

Number of Patients With the Incidence of Nausea/Vomiting Secondary · up to 48 hours after procedure

Group	Value	95% CI
Local Anesthetic (LA Group)	0
B Group	0

Number of Patients With Respiratory Depression Secondary · up to 48 hours after procedure

Group	Value	95% CI
Local Anesthetic (LA Group)	0
B Group	0

Number of Patients With Local Anesthetic Toxicity Secondary · up to 48 hours after procedure

Group	Value	95% CI
Local Anesthetic (LA Group)	0
B Group	0

Number of Patients With Incidence of Pneumothorax Secondary · up to 48 hours after procedure

Group	Value	95% CI
Local Anesthetic (LA Group)	0
B Group	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.