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

NCT03899701 | Withdrawn DMC

• 1 other identifier: 2019-9952
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  30 minutes - 2 hours after procedure

• Number of Patients with Prolong sensory deficit

  7 days after procedure

• Use of Supplemental Opioid greater than 100mcg of Fentanyl

  Within 4 hours

Study Arms (1)

PEC I and PEC II block

EXPERIMENTAL

Ultrasound guided nerve block group.

Procedure: PEC I and PEC II blocks

Interventions

PEC I and PEC II blocks PROCEDURE

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.

PEC I and PEC II block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center- Wakefield Campus

The Bronx, New York, 10467, United States

Location

Related Publications (3)

• 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.

  PMID: 29740019 BACKGROUND

• 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.

  PMID: 29861803 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

Study Officials

• Celina Joco

  Montefiore Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 2, 2019
• Study Start: November 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)