Effective Use of Pecs and Transversus Thoracics Plane Blocks for Subcutaneous Cardiac Pacemaker Insertion: A Case Series

Effective Use of PEC I, PEC II and Transversus Thoracics Muscle Plane Blocks for Subcutaneous Cardiac Pacemaker Insertion: A Case Series

Participants that undergo permanent cardiac pacemaker implantation can often present with challenging anesthetic management plans for the anesthesia provider. Typically, these procedures are performed in electrophysiology labs that are often in remote locations away from the main operating room suite. This presents the logistic challenges of not having standard anesthesia machines, equipment and medications readily available for these cases.Currently, the majority of these cases are done under local anesthesia with light to moderate sedation. However, when it comes to inserting more complex devices such as implantable cardiac defibrillators and cardiac resynchronization therapy devices, participants may not be able to tolerate these more invasive and painful procedures with only local anesthetic as the primary mode of analgesia.

Ultrasound-guided regional anesthetic techniques, in particular the pectoralis nerve blocks (PEC I and II) and the Transversus Thoracic Muscle plane block (TTP), offer an alternative mode of analgesia for these participants. PEC I blocks target the lateral and medial pectoral nerves by injecting local anesthetic in the fascial plane between the pectoralis major and minor muscles. PEC II blocks supplement the PEC I block by targeting the intercostal nerves with local anesthetic injected between the pectoralis minor and serratus anterior muscles. The transversus thoracic plane block targets the anterior cutaneous branches of the intercostal nerves. In combination, these four blocks would provide analgesia of the upper anterior chest wall.(3)These would provide effective analgesia of the upper anterior chest wall.(7).

However, there is a paucity of studies on the use of PEC blocks in cardiac pacemaker implantation procedures. There is a case report from 2014 on a 71 year-old male with an ejection fraction of 20% undergoing CRTD implantation, which showed that PECs block with moderate sedation using dexmedetomidine could be safely utilized to provide effective analgesia for the procedure.11 However, this was not a subcutaneous ICD that required tunneling of the coils. Thus there are no randomized controlled studies to investigate whether the use of peripheral nerve blocks as primary anesthetic choice could be a viable alternative for multiple participants undergoing subcutaneous ICD placement.

Study Overview

• Status: Withdrawn
• Conditions: Anesthesia, Local
• Intervention / Treatment: Procedure: PEC I and PEC II blocks

Detailed Description

This is a randomized controlled study evaluating the effectiveness of PEC I, PEC II, Transversus Thoracic plane blocks as the primary anesthetic in participants undergoing subcutaneous implantable defibrillator. There will be two groups; the nerve block group vs. general anesthesia group. The participants in the nerve block group will receive an ultrasound-guided nerve block in the electrophysiology suite prior to the start of the procedure. Participants will get a PEC I block with 10ml of 0.375% ropivacaine, PEC II block with 15ml of 0.375% ropivacaine, 15ml of 0.375% ropivacaine for TTP. PEC I block entails injecting local anesthesia between the pectoralis major and pectoralis minor muscles to anesthetize the medial and lateral pectoral nerves. PEC II block entails injecting local anesthetic between the pectoralis minor and serratus anterior muscles to block the upper intercostal nerves. For Tranversus Thoracic Plane block, local anesthetic will be injected between the internal intercostal muscle and the Transversus Thoracic muscle. The participants in the nerve block group will get mild sedation during the nerve blocks (midazolam 1-2mg IV and fentanyl 50-100mcg IV). After block placement, patient will be given a 0.3mcg/kg bolus of dexmedetomidine, then an infusion of dexmedetomidine 0.4mcg/kg/hr- 0.7mcg/kg/hr r +/- propofol 25mcg/kg/min-100mcg/kg/min for sedation. The general anesthesia group of participants will get the current standard of care with an endotracheal tube with a combination of IV induction medications and volatile anesthetic. Research assistant will hand an enclosed envelope to the anesthesiologists with the name of the group consented patient will be in.

Intraoperatively, the anesthesiologist will note if supplemental opioids and local anesthetic was required. Postoperatively, the PACU nurse will be asked to document pain scores according to the Visual Analog Scale (VAS) and total dose of opioids given. The distribution of the sensory block and motor weakness will be documented in the anesthesiologist's PACU discharge note. For postoperative data collection, opioid consumption totals and the pain scores at 30 minutes after arrival in PACU and at discharge.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center- Wakefield Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient undergoing cardiac pacemaker placement Age 18 and above ASA II-IV

Exclusion Criteria:

• Patient refusal
• Inability to understand and sign consent
• Infection at the injection site
• Known allergy or hypersensitivity to ropivacaine or other amide local anesthetics
• Coagulopathy (INR > 1.5)
• Use of anticoagulant drugs that have not been discontinued in an appropriate amount of time before the surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEC I and PEC II block; Ultrasound guided nerve block group.	Procedure: PEC I and PEC II blocks; Participants will get a PEC I block with 10ml of 0.375% ropivacaine and a PEC II block with 20ml of 0.375% ropivacaine using ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Addition of local anesthetic by Interventionalist	The primary objective is to evaluate the utilization of perioperative rescue medications, including the supplementation of local anesthesia by the Internationalist.	within 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of pain at the incision site at procedure start time	Presence of pain at the incision site at procedure start time	20 minutes after block
VAS Scores at 30 minutes after procedure and at discharge time	Comparison of VAS scores at 30 minutes after the procedure and at discharge time	30 minutes - 2 hours after procedure
Number of Patients with Prolong sensory deficit	Long-term follow-up (7 days) of prolong sensory deficit to the chest area	7 days after procedure
Use of Supplemental Opioid greater than 100mcg of Fentanyl	The use of more than 100mcg of fentanyl by the anesthesiologists doing the case	Within 4 hours

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Study Director: Celina Joco, Montefiore Medical Center

Publications and helpful links

General Publications

• Kaya E, Sudkamp H, Lortz J, Rassaf T, Janosi RA. Feasibility and safety of using local anaesthesia with conscious sedation during complex cardiac implantable electronic device procedures. Sci Rep. 2018 May 8;8(1):7103. doi: 10.1038/s41598-018-25457-x.
• Kim DH, Kim S, Kim CS, Lee S, Lee IG, Kim HJ, Lee JH, Jeong SM, Choi KT. Efficacy of Pectoral Nerve Block Type II for Breast-Conserving Surgery and Sentinel Lymph Node Biopsy: A Prospective Randomized Controlled Study. Pain Res Manag. 2018 May 15;2018:4315931. doi: 10.1155/2018/4315931. eCollection 2018.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2019-9952

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No identifiable patient's data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No