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PECS Study for CIED Implantation Surgery

Primary Purpose

Pain, Postoperative, Child, Adolescent

Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration
Bupivacaine 0.25% with epinephrine 1:200000 by wound infiltration only
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PECS block

Infiltration

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postoperative morphine consumption
Amount of morphine or morphine equivalents used after surgery

Secondary Outcome Measures

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.
Incidence of nausea/emesis postoperatively
Any self-reported episodes of nausea and any emesis will be recorded
Incidence of pruritus
Any self-reported episodes of pruritus will be recorded.
Adverse events
Any occurrence of hematoma, pneumothorax, lung injury or local anesthesia toxicity will be recorded
Time to discharge from recovery room
Time from admission to recovery room to discharge from recovery room

Full Information

First Posted
September 28, 2020
Last Updated
April 10, 2023
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT04577690
Brief Title
PECS Study for CIED Implantation Surgery
Official Title
Pectoral Nerve (PECS) Block for Cardiac Implantable Electronic Devices (CIED) Implantation Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Child, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Masking Description
The nursing staff in the post anesthesia care unit, patient and outcome assessors will be blinded to the patient allocation.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PECS block
Arm Type
Experimental
Arm Description
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.
Arm Title
Infiltration
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration
Other Intervention Name(s)
PECS block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% with epinephrine 1:200000 by wound infiltration only
Other Intervention Name(s)
Infiltration
Intervention Description
The EP cardiologist will administer Bupivacaine 0.25% with epinephrine 1:200000 by infiltrating the wound after surgery is complete.
Primary Outcome Measure Information:
Title
Postoperative morphine consumption
Description
Amount of morphine or morphine equivalents used after surgery
Time Frame
0 hours
Secondary Outcome Measure Information:
Title
Severity of pain
Description
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 hospital
Title
Incidence of nausea/emesis postoperatively
Description
Any self-reported episodes of nausea and any emesis will be recorded
Time Frame
Until discharge from recovery room, assessed up to 2 days
Title
Incidence of pruritus
Description
Any self-reported episodes of pruritus will be recorded.
Time Frame
Until discharge from recovery room, assessed up to 2 days
Title
Adverse events
Description
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
Title
Time to discharge from recovery room
Description
Time from admission to recovery room to discharge from recovery room
Time Frame
Until discharge from recovery room, assessed up to 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Taylor
Phone
416-813-7445
Email
katherine.taylor@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Carolyne Pehora
Phone
416-813-7654
Ext
202406
Email
carolyne.pehora@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Taylor
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Taylor
Phone
416-813-7445
Email
katherine.taylor@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Carolyne Pehora
Phone
416-813-7654
Ext
202406
Email
carolyne.pehora@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Anica Bulic
First Name & Middle Initial & Last Name & Degree
Farrukh Munshey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29628849
Citation
Froyshteter AB, Bhalla T, Tobias JD, Cambier GS, Mckee CT. Pectoralis blocks for insertion of an implantable cardioverter defibrillator in two patients with Duchenne muscular dystrophy. Saudi J Anaesth. 2018 Apr-Jun;12(2):324-327. doi: 10.4103/sja.SJA_624_17.
Results Reference
background
PubMed Identifier
25120950
Citation
Fujiwara A, Komasawa N, Minami T. Pectoral nerves (PECS) and intercostal nerve block for cardiac resynchronization therapy device implantation. Springerplus. 2014 Aug 5;3:409. doi: 10.1186/2193-1801-3-409. eCollection 2014.
Results Reference
background
PubMed Identifier
31273773
Citation
Al Ja'bari A, Robertson M, El-Boghdadly K, Albrecht E. A randomised controlled trial of the pectoral nerves-2 (PECS-2) block for radical mastectomy. Anaesthesia. 2019 Oct;74(10):1277-1281. doi: 10.1111/anae.14769. Epub 2019 Jul 4.
Results Reference
background
PubMed Identifier
30396100
Citation
Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65. doi: 10.1016/j.jclinane.2018.10.040. Epub 2018 Nov 3.
Results Reference
background
PubMed Identifier
27315180
Citation
Amir A, Jolin S, Amberg S, Nordstrom S. Implementation of Pecs I and Pecs II Blocks as Part of Opioid-Sparing Approach to Breast Surgery. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):544-5. doi: 10.1097/AAP.0000000000000401. No abstract available.
Results Reference
background
PubMed Identifier
25376971
Citation
Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
Results Reference
background
PubMed Identifier
21831090
Citation
Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
Results Reference
background
PubMed Identifier
30052231
Citation
Kumar KN, Kalyane RN, Singh NG, Nagaraja PS, Krishna M, Babu B, Varadaraju R, Sathish N, Manjunatha N. Efficacy of bilateral pectoralis nerve block for ultrafast tracking and postoperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):333-338. doi: 10.4103/aca.ACA_15_18.
Results Reference
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PECS Study for CIED Implantation Surgery

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