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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 to 48 hours after surgery
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My child is under 18 and needs heart defect repair.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 to 48 hours after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 to 48 hours after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
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
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
2,364 Previous Clinical Trials
3,420,600 Total Patients Enrolled
The Society of Pediatric AnesthesiaUNKNOWN
Lisa M Einhorn, MDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
66 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a long-term pain condition.I am on opioid medication at the time of my surgery.I will be on a breathing machine after surgery.I have had surgery that involved opening my chest.My child is under 18 and needs heart defect repair.
Research Study Groups:
This trial has the following groups:- Group 1: Regional Anesthesia
- Group 2: Wound Infiltration
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Federal Drug Administration accepted Regional Anesthesia as a legitimate form of treatment?
"Owing to the Phase 4 trial status of Regional Anesthesia, our team considered it safe and gave it a rating of 3."
Answered by AI
Are there opportunities still available to join this experiment?
"Clinicaltrials.gov confirms that the medical experiment is actively seeking volunteers, with the initial post being made on March 29th 2023 and its most recent update occurring on the same date."
Answered by AI
What is the current enrollment limit of this research trial?
"Affirmative, the particulars hosted on clinicaltrials.gov signal that this medical study is actively recruiting subjects. This research trial was initially created on March 29th 2023 and last modified then as well; 42 participants are required from a single site."
Answered by AI
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