PECS Study for CIED Implantation Surgery (NCT04577690) | Clinical Trial Compass
RecruitingPhase 4
PECS Study for CIED Implantation Surgery
Canada48 participantsStarted 2019-12-01
Plain-language summary
We aim to determine whether pectoral nerve block (PECS) performed after induction of anesthesia but before surgical incision results less opioid use in the post operative period compared with local infiltration alone in children undergoing Cardiac Implantable Electronic Device (CIED) surgery.
Who can participate
Age range
3 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
• All patients 3-18 years undergoing CIED surgery in the chest
Exclusion Criteria:
* Children \< 3 years of age at time of procedure as bupivacaine is not licensed for this age group.
* No parental or patient consent
* Allergy to bupivacaine
* Pregnancy or lactation
* Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 4 trial studying a nerve block technique called PECS for kids and teenagers getting a cardiac device implanted, can you explain what the PECS block actually involves and whether it would be used differently than what my child would normally receive for pain control after this surgery?
2The trial is specifically measuring how much morphine children need after surgery — what does that tell us about what the researchers are trying to prove, and how might using less opioid pain medication actually affect my child's recovery?
3Since this trial is still actively recruiting, what would my child's experience look like if they participated — would they receive the PECS block for certain, or is there a chance they'd be in a comparison group that doesn't get it?
4Given that my child is having cardiac device implantation surgery, which already carries its own risks, how does adding an experimental regional nerve block fit into the overall safety picture, and what are the known risks of the PECS technique in children specifically?
5Are there standard pain management approaches already used at your hospital for this type of surgery in kids, and how does what this trial is testing compare to what my child would receive if we chose not to participate?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.