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Local Anesthetic
Paravertebral Nerve Block for Congenital Heart Disease
Phase 4
Recruiting
Led By Justin B Long, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weigh of 2.5 kilograms or more at the time of surgery
Neonate or Infant (<12 months age) at the time of surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 24 hours after surgery
Awards & highlights
Study Summary
This trial will study whether a single-shot paravertebral nerve block is effective in providing intraoperative and postoperative pain control in infants undergoing a thoracotomy for coarctation of the aorta, by comparing consumption of narcotics in the standard of care and intervention groups.
Who is the study for?
This trial is for infants under 12 months old weighing at least 2.5 kilograms, undergoing thoracotomy for aortic coarctation repair. They must have a parent or guardian who can consent to the study. Infants already intubated, with ongoing infections, blood clotting issues, or allergies to local anesthetics cannot participate.Check my eligibility
What is being tested?
The study tests if a single-shot paravertebral nerve block can better manage pain during and after surgery compared to standard anesthesia care in neonates having heart surgery. It measures how much narcotic pain relief (morphine equivalents) each group needs.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, possible nerve damage, low blood pressure due to anesthesia, and allergic reactions to the local anesthetic used in the nerve block.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weighed more than 2.5 kilograms at the time of my surgery.
Select...
My child is under 12 months old and needs surgery.
Select...
I am having surgery for a narrowed aorta through an incision on my left side.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the end of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Morphine equivalents
Secondary outcome measures
Change in plasma epinephrine levels
Near infrared spectroscopy (NIRS) values
Postoperative ventilation time
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Paravertebral Nerve BlockExperimental Treatment1 Intervention
Participants in the experimental arm will undergo an anesthetic that includes the regional anesthetic technique, paravertebral nerve block.
Group II: Standard of Care AnesthesiaActive Control1 Intervention
Participants in the control arm will undergo an anesthetic consistent with the standard of care.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,642 Previous Clinical Trials
2,563,872 Total Patients Enrolled
Justin B Long, MDPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weighed more than 2.5 kilograms at the time of my surgery.My parent or guardian cannot or will not give consent for me.You are allergic to local anesthetics.I was on a breathing machine before surgery but may have been taken off it.I currently have a severe infection in my blood or a skin infection on my back.My parent or guardian agrees to participate and can sign the consent form.You have a known problem with your blood clotting.My child is under 12 months old and needs surgery.I am having surgery for a narrowed aorta through an incision on my left side.
Research Study Groups:
This trial has the following groups:- Group 1: Paravertebral Nerve Block
- Group 2: Standard of Care Anesthesia
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
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