Blocks Alternative to Sedation

Regional Anesthesia for Cardiac Implantable Electronic Device Implantation

Current practice is to implant cardiac electronic devices using intravenous sedation with midazolam and fentanyl, as well as local injection of anesthetic (1-2). However, some patients do not tolerate sedation and develop nausea/vomiting, delirium/confusion, allergic reactions, and hemodynamic instability with sedation (2-4). Many patients are poor candidates for procedural sedation due to inadequate fasting before the procedure or prior adverse effects of procedural sedation. Pain control is usually adequate, but a large portion of patients still experience pain or discomfort at the implant site if the local anesthetic did not reach every component of the tissue in the surgical field. Meanwhile, nerve block procedures have been used for decades to improve peri-operative and post-operative pain and reduce sedation requirements. With the introduction of ultrasound, the investigators are able to direct delivery of local anesthetic to anesthetize the supraclavicular and pectoralis nerves that supply sensory/pain sensation to the surgical site. Similar techniques have been well described as safe and effective (5-10). The investigators hypothesize this will improve pain control during and after surgery, reduce or eliminate the need for intravenous sedation and improve the safety of the procedure.

Study Overview

• Status: Completed
• Conditions: Pacemaker Implantation; ICD Implantation
• Intervention / Treatment: Procedure: Nerve block

Detailed Description

Inpatients who are consented to have cardiac device implantation will be given study information as soon as the decision to implant a device is reached. The patients will have time to decide to participate in the study up until they are called for the procedure (2-72 hours, most commonly > 24 hours). The decision to participate in the study is conveyed to the investigator in the holding room, and written consent is obtained if the patient agrees to participate in the study.

The nerve block is performed in the holding room as a 2-step procedure by trained physicians.

After the nerve block approximately 30-60 minutes will be allowed for the anesthetic to take effect prior to the cardiac device implantation procedure. The patient will be monitored by the nurses in the holding room. Once the patient is taken to the operating room and prepped for the cardiac device implantation procedure, testing of the nerve blocks is performed. The superficial pin-prick test will be performed to determine the success of the SCN block, and a deeper test will be performed with a 22ga needle to ensure the deeper muscular layers are anesthetized and the PECs I block is successful. If both blocks are successful, the patient will receive optional light sedation with midazolam 0.01 mg/kg based on their preference, and the procedure can commence. If either the SCN or PECs blocks are not successful based on the sensation test, usual care is provided.

Immediately after the procedure, the patient is asked to rate the pain during the procedure on a numerical scale. Any adverse effects reported by the patient will be documented. The patient will then be reassessed 1 hour after the procedure in the holding room and then called the following day. One of the investigators will contact the patient by telephone on the following day (24hr later), and perform a similar assessment. The assessment will involve inquiring how the patient is feeling, documenting any unintended adverse effects, and asking the patient to rate their pain on a numerical scale.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre Res. Inc. (Ont.)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. > 18 years old,
2. Undergoing cardiac device implantation in the suprapectoral area of the chest.

Exclusion Criteria:

1. Prior neck surgery ipsilateral to the device implantation site
2. Infection over the injection site
3. BMI ≥ 35
4. Uncooperative patient
5. Patient unable to provide consent
6. Patient has a pre-existing implanted cardiac device in the left chest wall area
7. Device implantation is booked in less than 2 hours.

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute anesthesia of skin and tissue	Needle prick test will be used over the subjected area to assess the nerve block. This will be measured as binary outcome (1-yes blocked ; 0 - not blocked). The region of anesthesia will also be measured by using an illustration to demarcate the region of block on the skin. The dermatomal distribution of the block will be measured in cm2.	30 minutes after nerve block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain score analog will be used to quantify the amount of pain during the procedure. Pain analog score is between 1-10 (1 being no pain to 10 being severe pain).	0 hour of completion of device implant, 1 hour post procedure and 1 day post procedure.
IV sedation and pain	Quantify amounts(milligram) of additional sedation or pain relief required intravenously during the procedure	0 hour
Duration of procedure	Quantify time required to complete the block	0 hour
Safety of the nerve block	Any associated complications from the nerve blocks will be listed in a enumerated way and added together.	Day 1

Collaborators and Investigators

• Sponsor: Habib Khan
• Collaborators: London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 10942

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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