Adolescent, Child, Pain, Postoperative
Conditions
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.
Detailed description
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.
Interventions
DRUGBupivacaine 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.
DRUGBupivacaine 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.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The nursing staff in the post anesthesia care unit, patient and outcome assessors will be blinded to the patient allocation.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morphine consumption | 0 hours | Amount of morphine or morphine equivalents used after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of pain | 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. |
| Incidence of nausea/emesis postoperatively | Until discharge from recovery room, assessed up to 2 days | Any self-reported episodes of nausea and any emesis will be recorded |
| Incidence of pruritus | Until discharge from recovery room, assessed up to 2 days | Any self-reported episodes of pruritus will be recorded. |
| Adverse events | Until discharge from recovery room, assessed up to 2 days | Any occurrence of hematoma, pneumothorax, lung injury or local anesthesia toxicity will be recorded |
| Time to discharge from recovery room | Until discharge from recovery room, assessed up to 2 days | Time from admission to recovery room to discharge from recovery room |
Countries
Canada
Contacts
CONTACTKatherine Taylor
CONTACTCarolyne Pehora
PRINCIPAL_INVESTIGATORKatherine Taylor
The Hospital for Sick Children
Outcome results
None listed