Cardiac Implantable Electronic Device Implantation With and Without Pectoral Nerve Block

Sponsor

Changi General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03061292

Collaborator

(none)

120

Enrollment

Location

Arms

51.3

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac IED Implantation	Procedure: Pectoral Nerve Block Procedure: Without Pectoral Nerve Block	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 25, 2016

Anticipated Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Procedurist satisfaction scores [2 years]
Patient satisfaction scores [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changi General Hospital	Singapore		Singapore	529889

Sponsors and Collaborators

Changi General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Changi General Hospital

ClinicalTrials.gov Identifier:

NCT03061292

Other Study ID Numbers:

PECS

First Posted:

Feb 23, 2017

Last Update Posted:

Oct 8, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 8, 2020