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Local Anesthetic

Regional Anesthesia for Pediatric Heart Surgery

Phase 4
Recruiting
Led By Lisa M Einhorn, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children less than 18 years old presenting for primary atrial septal defect or ventricular septal defect repair
Be younger than 18 years old
Must not have
Current diagnosis of a chronic pain syndrome
Patients on opioid therapy at the time of surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 to 48 hours after surgery
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares two pain relief techniques after surgery in kids with heart disease to see which works best.

Who is the study for?
This trial is for children under 18 needing their first surgery to repair a hole in the heart (atrial or ventricular septal defect). They must not be on opioid painkillers, have had previous chest surgery, require breathing support after surgery, or have chronic pain conditions.
What is being tested?
The study compares two ways to manage pain after pediatric heart surgery: using regional anesthesia guided by ultrasound versus surgeon-applied wound numbing with Ropivacaine. It aims to see which method controls pain better.
What are the potential side effects?
Possible side effects include discomfort at the injection site, low blood pressure due to the anesthesia, allergic reactions to Ropivacaine, and rare nerve damage from needle placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child is under 18 and needs heart defect repair.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a long-term pain condition.
Select...
I am on opioid medication at the time of my surgery.
Select...
I will be on a breathing machine after surgery.
Select...
I have had surgery that involved opening my chest.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 to 48 hours after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 to 48 hours after surgery 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 Intensity as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Pain Intensity as measured by Numeric Rating Scale
Total amount of opioid medications administered

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: Regional AnesthesiaActive Control2 Interventions
Ultrasound guided blocks
Group II: Wound InfiltrationActive Control2 Interventions
Surgeon-delivered wound infiltration

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,455 Previous Clinical Trials
2,971,510 Total Patients Enrolled
The Society of Pediatric AnesthesiaUNKNOWN
Lisa M Einhorn, MDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
66 Total Patients Enrolled

Media Library

Ropivacaine 0.2% Injectable Solution (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05688670 — Phase 4
Ventricular Septal Defects Research Study Groups: Regional Anesthesia, Wound Infiltration
Ventricular Septal Defects Clinical Trial 2023: Ropivacaine 0.2% Injectable Solution Highlights & Side Effects. Trial Name: NCT05688670 — Phase 4
Ropivacaine 0.2% Injectable Solution (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05688670 — Phase 4
~5 spots leftby Mar 2025
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