Recruiting

Observational Study

Sponsor:

The Hospital for Sick Children

Code:

NCT04577690

Conditions

Pain, Postoperative

Child

Adolescent

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

Interventions

Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration

Bupivacaine 0.25% with epinephrine 1:200000 by wound infiltration only

Study Details

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.

Conditions

Pain, Postoperative

Child

Adolescent

Study ID

NCT04577690

Start date

Dec 1, 2019

Status verified date

Apr, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PECS block

A PECS block of 0.25 % bupivacaine with epinephrine 1:200000 (below the toxic dose limit of 3 mg/kg) in divided doses to cover the fascial planes identified in PECS I and PECS II. At the completion of surgery, the wound will be infiltrated with up to 0.2 ml/kg of 0.25 % bupivacaine into the wound.

active comparator: Infiltration

At the completion of surgery, the EP cardiologist will infiltrate the wound with up to 0.8 ml/kg of 0.25 % bupivacaine with epinephrine 1:200000.

Interventions

Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration

The anesthesiologist will administer bupivacaine 0.25% with epinephrine 1:200000 by PECS block after induction of anesthesia before surgical incision. The EP cardiologist will also administer bupivacaine 0.25% with epinephrine 1:200000 by infiltrating the wound after surgery is complete.

Bupivacaine 0.25% with epinephrine 1:200000 by wound infiltration only

The EP cardiologist will administer Bupivacaine 0.25% with epinephrine 1:200000 by infiltrating the wound after surgery is complete.

Primary outcome measure

  • Postoperative morphine consumption [ Time Frame: 0 hours ]

Central Contacts and Locations

Central contacts

Katherine Taylor

416-813-7445katherine.taylor@sickkids.ca

Carolyne Pehora

416-813-7654carolyne.pehora@sickkids.ca

Locations

Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Katherine Taylor

416-813-7445katherine.taylor@sickkids.ca

Carolyne Pehora

416-813-7654carolyne.pehora@sickkids.ca

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2026-04-23.