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
-- One group will be treated with numbing medicine at the incision site to lower their pain after surgery
-- The other group will have the nerves around the incision site blocked using ultrasound guidance to lower their pain after surgery
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.
- Get a random assignment (like a coin flip) to 1 of 2 groups
-- One group will be treated with numbing medicine at the incision site to lower their pain after surgery
-- The other group will have the nerves around the incision site blocked using ultrasound guidance to lower their pain after surgery
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.
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
A Randomized Double-Blinded Pilot Study
Principal Investigator
Lisa
Einhorn
Protocol Number
PRO00111671
NCT ID
NCT05688670
Phase
N/A
Enrollment Status
OPEN TO ACCRUAL