Blocks Alternative to Sedation

NCT04842227 | Completed

• 1 other identifier: 10942
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pacemaker Implantation; ICD Implantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain score

  0 hour of completion of device implant, 1 hour post procedure and 1 day post procedure.

• IV sedation and pain

  0 hour

• Duration of procedure

  0 hour

• Safety of the nerve block

  Day 1

Interventions

Nerve block PROCEDURE

Step 1: A small amount of local anesthetic (3-5cc of 0.5% ropivacaine) is administered under ultrasound guidance in the area of the supraclavicular nerve at the base of the neck under sterile conditions. This provides dense anesthesia of the skin and eliminates the need to introduce larger quantities of local anesthetic directly to the skin around the incision (usually 20mL). The second step involves introducing 10-15cc of 0.5% ropivacaine under ultrasound guidance into the compartment between the pectoralis major and minor muscles to anesthetize the medial and lateral pectoral nerves. NOTE: Usual care involves "blind" administration of local anesthetic diffusely to the tissues in this region without targeting any particular nerves, and requires larger volumes of anesthetic (40mL for the "blind approach" vs 10-15mL for the nerve block).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Habib Khan: lead
• London Health Sciences Centre: collaborator

Study Sites (1)

London Health Sciences Centre Res. Inc. (Ont.)

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Interventions

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor in Cardiology

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)