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Regional Anesthesia

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

Phase 4
Waitlist Available
Led By Olga Pewelek, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1.5 hours post procedure in post anesthesia care unit (pacu)
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether truncal blocks are effective and safe for pacemaker and AICD implantation in children, and whether they decrease the amount of narcotic medications needed.

Eligible Conditions
  • Analgesia
  • ICD Implantation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1.5 hours post procedure in post anesthesia care unit (pacu)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1.5 hours post procedure in post anesthesia care unit (pacu) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Pain as measured by the visual analog scale (VAS) pain score

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: B groupActive Control1 Intervention
Group II: Local Anesthetic (LA Group)Active Control1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
348,037 Total Patients Enrolled
1 Trials studying Analgesia
50 Patients Enrolled for Analgesia
Olga Pewelek, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
~6 spots leftby Dec 2025
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