PECS Study for CIED Implantation Surgery

NCT04577690 | Recruiting Phase 4

• 1 other identifier: 1000065122
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Child; Adolescent

Outcome Measures

Primary Outcomes (1)

• Postoperative morphine consumption

  Amount of morphine or morphine equivalents used after surgery

  0 hours

Secondary Outcomes (5)

• Severity of pain

  0 hours, 6 hours, 12 hours and at discharge from hospital

• Incidence of nausea/emesis postoperatively

  Until discharge from recovery room, assessed up to 2 days

• Incidence of pruritus

  Until discharge from recovery room, assessed up to 2 days

• Adverse events

  Until discharge from recovery room, assessed up to 2 days

• Time to discharge from recovery room

  Until discharge from recovery room, assessed up to 2 days

Study Arms (2)

PECS block

EXPERIMENTAL

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.

Drug: Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration

Infiltration

ACTIVE COMPARATOR

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.

Drug: Bupivacaine 0.25% with epinephrine 1:200000 by wound infiltration only

Interventions

Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration DRUG

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.

Also known as: PECS block

PECS block

Bupivacaine 0.25% with epinephrine 1:200000 by wound infiltration only DRUG

The EP cardiologist will administer Bupivacaine 0.25% with epinephrine 1:200000 by infiltrating the wound after surgery is complete.

Also known as: Infiltration

Infiltration

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All patients 3-18 years undergoing CIED surgery in the chest

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Related Publications (8)

• 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.

  PMID: 29628849 BACKGROUND

• 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.

  PMID: 25120950 BACKGROUND

• 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.

  PMID: 31273773 BACKGROUND

• 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.

  PMID: 30396100 BACKGROUND

• 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.

  PMID: 27315180 BACKGROUND

• 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.

  PMID: 25376971 BACKGROUND

• 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.

  PMID: 21831090 BACKGROUND

• 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.

  PMID: 30052231 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Katherine Taylor

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Taylor

CONTACT

416-813-7445; katherine.taylor@sickkids.ca

Carolyne Pehora

CONTACT

416-813-7654; carolyne.pehora@sickkids.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The nursing staff in the post anesthesia care unit, patient and outcome assessors will be blinded to the patient allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 8, 2020
• Study Start: December 1, 2019
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)