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Cardiac Implantable Electronic Device Implantation With and Without Pectoral Nerve Block

NCT03061292 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-10-08

No results posted yet for this study

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

Interventions

PROCEDURE

Pectoral Nerve Block

PROCEDURE

Without Pectoral Nerve Block

Sponsors & Collaborators

  • Changi General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-25
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03061292 on ClinicalTrials.gov