Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04577690
Status:
RECRUITING
Last Update Posted:
2023-04-11
First Post:
2020-09-28
Brief Title:
PECS Study for CIED Implantation Surgery
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Pectoral Nerve PECS Block for Cardiac Implantable Electronic Devices CIED Implantation Surgery
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 08 mlkg of 025 bupivacaine with epinephrine 1 200000 divided in two equal volumes between the two planes by the anaesthesiologist and local infiltration up to 02 mlkg of 025 bupivacaine with epinephrine 1200000 by the surgeon
Group 2 will receive local infiltration up to 08 mlkg 025 bupivacaine with epinephrine 1200000 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
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 08 mlkg of 025 bupivacaine with epinephrine 1 200000 divided in two equal volumes between the two planes by the anaesthesiologist and local infiltration up to 02 mlkg of 025 bupivacaine with epinephrine 1200000 by the surgeon
Group 2 will receive local infiltration up to 08 mlkg 025 bupivacaine with epinephrine 1200000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None