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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03061292
Enrollment
120
Registered
2017-02-23
Start date
2016-07-25
Completion date
2020-11-30
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac IED Implantation

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.

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.

Interventions

PROCEDUREWithout Pectoral Nerve Block

Sponsors

Changi General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Eligibility

Sex/Gender
ALL
Age
21 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of hypoxia, hypotension and hypopnea in the perioperative period2 years
Perioperative pain scores2 years
Post-anaesthetic discharge score2 years
Total dose of sedation used2 years
Perioperative sedation scores2 years

Secondary

MeasureTime frame
Patient satisfaction scores2 years
Procedurist satisfaction scores2 years

Countries

Singapore

Contacts

Primary ContactVern Hsen Tan, MBBS
vern_hsen_tan@cgh.com.sg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026