Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Location status: Recruiting
Location contact
Anica Bulic
SUB_INVESTIGATOR
Carolyne Pehora
CONTACT
416-813-7654 ext. 202406
Farrukh Munshey
SUB_INVESTIGATOR
Katherine Taylor
CONTACT
NCT Number: NCT04577690
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.
Interested in participating?
Request Info3 year–18 year
All sexes
Interventional
Phase 4
Toronto, Ontario, M5G 1X8, Canada
Location status: Recruiting
Anica Bulic
SUB_INVESTIGATOR
Carolyne Pehora
CONTACT
416-813-7654 ext. 202406
Farrukh Munshey
SUB_INVESTIGATOR
Katherine Taylor
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
The EP cardiologist will administer Bupivacaine 0.25% with epinephrine 1:200000 by infiltrating the wound after surgery is complete.
Other names: Infiltration
Time frame: 0 hours
Amount of morphine or morphine equivalents used after surgery
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.
Time frame: Until discharge from recovery room, assessed up to 2 days
Any self-reported episodes of nausea and any emesis will be recorded
Time frame: Until discharge from recovery room, assessed up to 2 days
Any self-reported episodes of pruritus will be recorded.
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
Time frame: Until discharge from recovery room, assessed up to 2 days
Time from admission to recovery room to discharge from recovery room
Contact information is provided by the study sponsor or research team.
The Hospital for Sick Children
Other
Pectoral Nerve (PECS) Block for Cardiac Implantable Electronic Devices (CIED) Implantation Surgery
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.
NCT04064853
Adolescent, Attitude
Malmö, Skåne County, Sweden
View Trial DetailsNCT02248493
Child, Neurologic Manifestations
Kaunas, Lithuania
View Trial DetailsNCT07731295
Chemically-Induced Disorders, Mental Disorders
Providence, Rhode Island, United States
View Trial DetailsNCT07517679
Neurologic Manifestations, Pain
Lexington, Kentucky, United States
View Trial Details