Regional Anesthesia following Pediatric Cardiac Surgery

Purpose of this Study

If your child is eligible and you allow them to join the study, they will get a random assignment (like a coin flip) to 1 of 2 groups:<ul>
<li>One group will be treated with numbing medicine at the incision site to lower their pain after surgery</li>
<li>The other group will have the nerves around the incision site blocked using ultrasound guidance to lower their pain after surgery</li></ul>
Both of these procedures are routinely performed by clinicians to help manage pain after surgery. We do not know which procedure is better for most children, and we hope this study will help us find out.

We will also ask you and your child to fill out a few surveys during your time in the hospital. We will call you about 30 days after your child's procedure to see how they are doing and end their study participation.

Who Can Participate?

Eligibility

Children ages 17 and under who are scheduled to have surgery at Duke to repair either a primary atrial septal defect or a ventricular septal defect.

For more information about who can join this study, please contact the study team at julia.hoang@duke.edu.

Age Range

0-17

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

We are doing this study to compare two different procedures to lower the pain associated with heart surgery for children. We want to know if one of the procedures has better success than the other.

Locations

Duke University Hospital

Visit Timing

Weekdays
Weekends
Evenings

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

Pain Control with Regional Anesthesia following Pediatric Cardiac Surgery:
A Randomized Double-Blinded Pilot Study

Principal Investigator

Lisa
Einhorn

Protocol Number

PRO00111671

NCT ID

NCT05688670

Phase

N/A

Enrollment Status

Open to Enrollment