PECS Study for CIED Implantation Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain, Postoperative, Child, Adolescent

Intervention / Treatment
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* Drug: Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration
* Drug: Bupivacaine 0.25% with epinephrine 1:200000 by wound infiltration only


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Using a computer-generated table, patients will be randomized to one of two groups: PECS block or Local infiltration only. Group allocation are concealed in sealed, opaque, sequentially numbered envelopes that are opened on the day of surgery.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PECS block<br>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. | Drug: Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration<br>* 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.<br>* Other names: PECS block;|
| Active Comparator: Infiltration<br>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. | Drug: Bupivacaine 0.25% with epinephrine 1:200000 by wound infiltration only<br>* The EP cardiologist will administer Bupivacaine 0.25% with epinephrine 1:200000 by infiltrating the wound after surgery is complete.<br>* Other names: Infiltration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morphine consumption | Amount of morphine or morphine equivalents used after surgery | 0 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of pain | 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. | 0 hours, 6 hours, 12 hours and at discharge from hospital | 
| Incidence of nausea/emesis postoperatively | Any self-reported episodes of nausea and any emesis will be recorded | Until discharge from recovery room, assessed up to 2 days | 
| Incidence of pruritus | Any self-reported episodes of pruritus will be recorded. | Until discharge from recovery room, assessed up to 2 days | 
| Adverse events | Any occurrence of hematoma, pneumothorax, lung injury or local anesthesia toxicity will be recorded | Until discharge from recovery room, assessed up to 2 days | 
| Time to discharge from recovery room | Time from admission to recovery room to discharge from recovery room | Until discharge from recovery room, assessed up to 2 days |