Cardiac Implantable Electronic Device Implantation With and Without Pectoral Nerve Block

A Randomized, Controlled Trial on Patients Undergoing Cardiac Implantable Electronic Device Implantation With Local Anaesthesia and Sedation With and Without Pectoral Nerve Block

Implantation of cardiac implantable electronic devices are generally carried out using intermittent intravenous conscious sedation combined with local anaesthesia. The main advantage of this technique is in avoiding the potential risks of general anaesthesia. However, the use of this Sedation - Local Anaesthesia technique is not without complications. Peri -procedural hypoxaemia and hypotension are well recognised complications of this technique.

The pectoral nerves (Pecs) blocks are novel techniques to block the pectoral, intercostobrachial, third to sixth intercostals, and the long thoracic nerves. PECS block targets the lateral and median pectoral nerves at an interfascial plane between the pectoralis major and minor muscles.

A case report by Fujiwara et al has described the use of this technique to provide good analgesia during and after these implantation procedures surgery. Pectoral nerves block along with minimal sedation has been used as a safe technique in our local set up as well.

Hence, we propose a randomized, single center, controlled trial on patients undergoing cardiac implantable electronic device implantation with local anaesthesia and sedation with and without Pectoral Nerve Block.

Study Overview

• Status: Unknown
• Conditions: Cardiac IED Implantation
• Intervention / Treatment: Procedure: Pectoral Nerve Block; Procedure: Without Pectoral Nerve Block

Detailed Description

Intervention group:

Pectoral nerve block will be performed by anaesthetist (not blinded) in cardiac catheterization laboratory using ultrasound guidance and strict aseptic technique.

Control group:

A sham "block" will be performed by anaesthetist in cardiac catheterization laboratory using strict aseptic technique.

Patients of both groups will be monitored by the Cardiologist ( performing the procedure) and the Nurse from the monitoring room.

A minimum period of 15 minutes will be allowed following the block, prior to device implantation procedure by cardiologist.

Numeric rating scale (NRS) will be used for assessment of pain. The assessment will be carried out at every 15 minutes from the start of the procedure till the end of the procedure (0, 15, 30, 45, 60 minutes etc) and also at specific time points. Numerical rating scale will also be assessed when the patient experiences pain at any point and in the recovery room (0, 15, 30 and if needed, 45, 60 minutes).

Further post-operative pain scores will be collected at 4 hours and 8 hours post-procedure.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vern Hsen Tan, MBBS; Email: vern_hsen_tan@cgh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Recruiting
    • Changi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Fulfilled the indication for CIED implantation as defined in 2008 guidelines for device-based therapy of cardiac rhythm abnormalities

Exclusion Criteria:

• Pregnant
• Those who receives subcutaneous implantable cardioverter defibrillator
• Vulnerable subjects (children, prisoners, cognitive impaired persons)
• Known history of allergy to local anaesthetic medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pectoral Nerve Block; Patients undergoing cardiac implantable electronic device implantation with local anaesthesia and sedation with pectoral nerve block	Procedure: Pectoral Nerve Block
SHAM_COMPARATOR: Without Pectoral Nerve Block; Patients undergoing cardiac implantable electronic device implantation with local anaesthesia and sedation without pectoral nerve block	Procedure: Without Pectoral Nerve Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total dose of sedation used	2 years
Incidence of hypoxia, hypotension and hypopnea in the perioperative period	2 years
Perioperative sedation scores	2 years
Perioperative pain scores	2 years
Post-anaesthetic discharge score	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Procedurist satisfaction scores	2 years
Patient satisfaction scores	2 years

Collaborators and Investigators

• Sponsor: Changi General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 25, 2016
• Primary Completion (ANTICIPATED): November 1, 2020
• Study Completion (ANTICIPATED): November 1, 2020

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 19, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PECS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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