Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 3 to 18

Pectoral nerve block versus local numbing for children getting chest pacemaker or ICD placement

Official title: Pectoral Nerve (PECS) Block for Cardiac Implantable Electronic Devices (CIED) Implantation Surgery

Run by The Hospital for Sick Children · NCT04577690 · Data updated 2026-11-12

This test will see if giving a pectoral nerve block before implant surgery helps children need fewer opioids after chest device placement than local numbing alone.

Quick facts

PhasePhase 4
Study typeInterventional
Ages3 Years to 18 Years
SexAll
Enrollment48 (estimated)
SponsorThe Hospital for Sick Children
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedDecember 1, 2019
Main results expectedJanuary 1, 2028
Study endsJanuary 1, 2028
Registry record updatedApril 23, 2026
Trial IDNCT04577690 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 3 to 18 years who are having a cardiac implantable electronic device placed in the chest and whose parent/guardian provides consent are eligible.

Probably not a fit

Children under 3 years, those allergic to bupivacaine, or anyone with medical reasons that make regional anesthesia unsafe would not be expected to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, single-center trial at The Hospital for Sick Children comparing two pain-control approaches for pediatric cardiac device implantation. One group receives a pectoral nerve block plus limited local wound infiltration, and the other group receives local wound infiltration alone; both groups receive opioids as needed. The main outcome is postoperative opioid use and pain control in children aged 3–18 undergoing CIED surgery. The trial uses standard bupivacaine with epinephrine dosing and follows patients through the immediate postoperative period and early recovery at home.

Why it matters

Potential benefit: If successful, the pectoral nerve block could reduce the amount of opioids children need after device implantation and improve pain control with fewer side effects.

How similar studies have gone: Pectoral nerve blocks have shown improved analgesia and reduced opioid use in adult breast and chest surgery and in small pediatric case series, but large randomized data for pediatric CIED implantation are lacking.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Hospital for Sick Children
    Toronto, Ontario, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.