Clinical trial NCT04577690: PECS Study for CIED Implantation Surgery
Official title: Pectoral Nerve (PECS) Block for Cardiac Implantable Electronic Devices (CIED) Implantation Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Child
Adolescent
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 48
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postoperative morphine consumption
timeFrame: 0 hours
Secondary outcomes:
measure: Severity of pain
timeFrame: 0 hours, 6 hours, 12 hours and at discharge from hospital
measure: Incidence of nausea/emesis postoperatively
timeFrame: Until discharge from recovery room, assessed up to 2 days
measure: Incidence of pruritus
timeFrame: Until discharge from recovery room, assessed up to 2 days
measure: Adverse events
timeFrame: Until discharge from recovery room, assessed up to 2 days
measure: Time to discharge from recovery room
timeFrame: Until discharge from recovery room, assessed up to 2 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Katherine Taylor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.