Clinical trial NCT04842227: Blocks Alternative to Sedation
Official title: Regional Anesthesia for Cardiac Implantable Electronic Device Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pacemaker Implantation
ICD Implantation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre
First posted: 2021-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acute anesthesia of skin and tissue
timeFrame: 30 minutes after nerve block
Secondary outcomes:
measure: Pain score
timeFrame: 0 hour of completion of device implant, 1 hour post procedure and 1 day post procedure.
measure: IV sedation and pain
timeFrame: 0 hour
measure: Duration of procedure
timeFrame: 0 hour
measure: Safety of the nerve block
timeFrame: Day 1
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre Res. Inc. (Ont.)
state: Ontario
Study officials:
References: