Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04577690

PECS Study for CIED Implantation Surgery

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

The current anaesthetic management of CIED surgery at Sickkids is local anaesthetic infiltration by the EP cardiologist or a Pectoral nerve block (PECS) on an ad-hoc basis depending on the anaesthesiologist on a case by case basis. It is not known whether one technique provides better post- operative pain control and fewer adverse events than the other. In either case, the patient receives opioids as required during and after the procedure. Patients typically go home with a prescription for opioids to be taken for the first few days after surgery.

The PECS block is a recognized effective anaesthetic technique used for both intraoperative and postoperative pain control in adult breast surgery, chest wall procedures as well as one case report for CIED implantation and a small series in paediatric cardiac surgery. The advantages of the PECS block in these surgical procedures includes improved analgesia and reduced opioid use.

The investigators plan to conduct an RCT with two groups.

Group 1 will receive a PECS block (using 0.8 ml/kg of 0.25% bupivacaine with epinephrine 1: 200000 divided in two equal volumes between the two planes) by the anaesthesiologist and local infiltration (up to 0.2 ml/kg of 0.25% bupivacaine with epinephrine 1:200000) by the surgeon.

Group 2 will receive local infiltration (up to 0.8 ml/kg 0.25 % bupivacaine with epinephrine 1:200000) by the surgeon alone.

Both groups will be given opioids as rescue analgesics as deemed necessary during their procedure and as rescue analgesia postoperatively, so that no patient will have untreated pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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.

Other names: PECS block

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

Drug

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

Other names: Infiltration

Primary outcomes

  1. Postoperative morphine consumption

    Time frame: 0 hours

    Amount of morphine or morphine equivalents used after surgery

Secondary outcomes

  1. Severity of pain

    Time frame: 0 hours, 6 hours, 12 hours and at discharge from hospital

    Severity of pain will be measured using and Numerical Rating Score (NRS) or Face, Legs, Activity, Cry and Consolability (FLACC) score as appropriate for age.

  2. Incidence of nausea/emesis postoperatively

    Time frame: Until discharge from recovery room, assessed up to 2 days

    Any self-reported episodes of nausea and any emesis will be recorded

  3. Incidence of pruritus

    Time frame: Until discharge from recovery room, assessed up to 2 days

    Any self-reported episodes of pruritus will be recorded.

  4. Adverse events

    Time frame: Until discharge from recovery room, assessed up to 2 days

    Any occurrence of hematoma, pneumothorax, lung injury or local anesthesia toxicity will be recorded

  5. Time to discharge from recovery room

    Time frame: Until discharge from recovery room, assessed up to 2 days

    Time from admission to recovery room to discharge from recovery room

Study contacts

Contact information is provided by the study sponsor or research team.

Carolyne Pehora

CONTACT

[email protected]

416-813-7654 ext. 202406

Katherine Taylor

CONTACT

[email protected]

416-813-7445

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Oct 8, 2020
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.