Cardiac Implantable Electronic Device Implantation With and Without Pectoral Nerve Block

NCT03061292 | Unknown

• 1 other identifier: PECS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac IED Implantation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Procedurist satisfaction scores

  2 years

• Patient satisfaction scores

  2 years

Study Arms (2)

Pectoral Nerve Block

EXPERIMENTAL

Patients undergoing cardiac implantable electronic device implantation with local anaesthesia and sedation with pectoral nerve block

Procedure: Pectoral Nerve Block

Without Pectoral Nerve Block

SHAM COMPARATOR

Patients undergoing cardiac implantable electronic device implantation with local anaesthesia and sedation without pectoral nerve block

Procedure: Without Pectoral Nerve Block

Interventions

Pectoral Nerve Block PROCEDURE

Pectoral Nerve Block

Without Pectoral Nerve Block PROCEDURE

Without Pectoral Nerve Block

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

RECRUITING

Central Study Contacts

Vern Hsen Tan, MBBS

CONTACT

vern_hsen_tan@cgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 23, 2017
• Study Start: July 25, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

SG (1)