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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
Must not have
Parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent
Ongoing septicemia or localized skin infection on the back
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 24 hours after surgery
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

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.
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.
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 below
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My parent or guardian cannot or will not give consent for me.
Select...
I currently have a severe infection in my blood or a skin infection on my back.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Morphine equivalents
Secondary study objectives
Change in plasma epinephrine levels
Near infrared spectroscopy (NIRS) values
Postoperative ventilation time
+1 more

Awards & Highlights

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.

Trial 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.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,700 Previous Clinical Trials
2,604,568 Total Patients Enrolled
Justin B Long, MDPrincipal InvestigatorEmory University

Media Library

Paravertebral Nerve Block (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT03408340 — Phase 4
Congenital Heart Disease Research Study Groups: Paravertebral Nerve Block, Standard of Care Anesthesia
Congenital Heart Disease Clinical Trial 2023: Paravertebral Nerve Block Highlights & Side Effects. Trial Name: NCT03408340 — Phase 4
Paravertebral Nerve Block (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03408340 — Phase 4
~0 spots leftby Dec 2024
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