PECS Study for CIED Implantation Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-18
SponsorThe Hospital for Sick Children
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration
DrugThe 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
DrugThe EP cardiologist will administer Bupivacaine 0.25% with epinephrine 1:200000 by infiltrating the wound after surgery is complete.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: PECS blockExperimental treatment 1 intervention
Group B: InfiltrationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative morphine consumption
Amount of morphine or morphine equivalents used after surgery
Time frame
0 hoursSecondary outcomes
1
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.
Time frame
0 hours, 6 hours, 12 hours and at discharge from hospital2
Incidence of nausea/emesis postoperatively
Any self-reported episodes of nausea and any emesis will be recorded
Time frame
Until discharge from recovery room, assessed up to 2 days3
Incidence of pruritus
Any self-reported episodes of pruritus will be recorded.
Time frame
Until discharge from recovery room, assessed up to 2 days4
Adverse events
Any occurrence of hematoma, pneumothorax, lung injury or local anesthesia toxicity will be recorded
Time frame
Until discharge from recovery room, assessed up to 2 daysSponsors and contacts
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Source ClinicalTrials.gov