Regional Anesthesia for Pediatric Heart Surgery

Overseen By Julia Hoang

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Must not be taking: Opioids

Disqualifiers: Sternotomy, Intubation, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Perioperative period

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration.

Who Is on the Research Team?

Lisa M Einhorn, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Informed consent / assent provided

My child is under 18 and needs heart defect repair.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ultrasound guided regional anesthesia or surgeon-delivered wound infiltration during pediatric cardiac surgery

Perioperative period

Postoperative Monitoring

Pain intensity and opioid medication usage are monitored for 48 hours after surgery

48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Ropivacaine 0.2% Injectable Solution
• Wound infiltration

Trial Overview 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.

How Is the Trial Designed?

Group I: Regional Anesthesia Active Control 2 Interventions

Ultrasound guided blocks

Group II: Wound Infiltration Active Control 2 Interventions

Surgeon-delivered wound infiltration

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

The Society of Pediatric Anesthesia

Collaborator

Trials

1

Recruited

50+