NCT04577690 PECS Study for CIED Implantation Surgery
| NCT ID | NCT04577690 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The Hospital for Sick Children |
| Condition | Pain, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2019-12-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 48 participants in total. It began in 2019-12-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Katherine Taylor
PRINCIPAL INVESTIGATOR
The Hospital for Sick Children
Frequently Asked Questions
Who can join the NCT04577690 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Pain, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04577690 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04577690 currently recruiting?
Yes, NCT04577690 is actively recruiting participants. Contact the research team at katherine.taylor@sickkids.ca for enrollment information.
Where is the NCT04577690 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04577690 clinical trial?
NCT04577690 is sponsored by The Hospital for Sick Children. The principal investigator is Katherine Taylor at The Hospital for Sick Children. The trial plans to enroll 48 participants.