Pectoral nerve block versus local numbing for children getting chest pacemaker or ICD placement
Pectoral Nerve (PECS) Block for Cardiac Implantable Electronic Devices (CIED) Implantation Surgery
PHASE4 · The Hospital for Sick Children · NCT04577690
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
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | The Hospital for Sick Children (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04577690 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- Hospital for Sick Children — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Katherine Taylor — The Hospital for Sick Children
- Study coordinator: Katherine Taylor
- Email: katherine.taylor@sickkids.ca
- Phone: 416-813-7445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain, Postoperative, Child, Adolescent