PECS Study for CIED Implantation Surgery

Pain, Postoperative Clinical Trial

Official title:

Pectoral Nerve (PECS) Block for Cardiac Implantable Electronic Devices (CIED) Implantation Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04577690
• Other study ID #: 1000065122
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2019
• Est. completion date: January 1, 2024

Study information

• Verified date: April 2023
• Source: The Hospital for Sick Children
• Contact: Katherine Taylor
• Phone: 416-813-7445
• Email: katherine.taylor[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent
• Child
• Pain, Postoperative

Intervention

Drug:
• Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration
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.
• Bupivacaine 0.25% with epinephrine 1:200000 by wound infiltration only
The EP cardiologist will administer Bupivacaine 0.25% with epinephrine 1:200000 by infiltrating the wound after surgery is complete.

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morphine consumption	Amount of morphine or morphine equivalents used after surgery	0 hours
Secondary	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.	0 hours, 6 hours, 12 hours and at discharge from hospital
Secondary	Incidence of nausea/emesis postoperatively	Any self-reported episodes of nausea and any emesis will be recorded	Until discharge from recovery room, assessed up to 2 days
Secondary	Incidence of pruritus	Any self-reported episodes of pruritus will be recorded.	Until discharge from recovery room, assessed up to 2 days
Secondary	Adverse events	Any occurrence of hematoma, pneumothorax, lung injury or local anesthesia toxicity will be recorded	Until discharge from recovery room, assessed up to 2 days
Secondary	Time to discharge from recovery room	Time from admission to recovery room to discharge from recovery room	Until discharge from recovery room, assessed up to 2 days