A randomised, double-blind, controlled trial on patients undergoing cardiac implantable electronic device implantation with local anaesthesia and sedation with and without pectoral nerve block

Abstract

Abstract Background Implantation of cardiac implantable electronic devices (CIED) are generally carried out with local anaesthesia (LA) and sedation. However, peri-procedural hypoxaemia and hypotension are well recognised complications of this technique primarily due to sedation effect. The pectoral nerves block (PECs) targets the lateral and median pectoral nerves at interfascial plane between pectoralis major and minor muscles. This technique potentially lower sedation usage and therefore lower sedation-related complications. There is, however, no randomised study to date comparing CIED procedure with and without PECs block. Methods We randomly assigned 64 patients undergoing CIED implantation procedure with LA (subcutaneous lignocaine 1%) and sedation (intermittent bolus of intravenous midazolam and fentanyl according to pain score) with (32 patients) and without (32 patients) PECs. Those received PECs with be given 10 mls of 0.25% ropivacaine. Primary endpoint was total dose of sedation used. Secondary endpoints were perioperative incidence of hypoxia, hypotension and hypopnea, perioperative pain scores, proceduralists' and patients' satisfaction scores. Results Overall, majority were male (64.1%), mean age of 67.9±10.7 years, mean BMI of 25.7±5.5 kg/m2 and mean lignocaine 1% dosage was 15.3±3.1mL. Compare to those with and without PECs, there was no significant difference in baseline characteristics. The mean fentanyl [25.3±25.0 mcg (95% CI: 16.3–34.3) vs 32.2±26.7 mcg (95% CI: 22.6–41.8), p=0.29] and midazolam dosage [0.7±0.7mg (95% CI: 0.4–0.9) vs 0.8±0.8 (95% CI: 0.6±1.1), p=0.36] were trended lower in PECs compared to without PECs. PECs group had lower pain score at recovery (OR: 1.7, 95% CI: 0.38–7.93, p=0.48). Proceduralists' and patients' satisfaction score were trended higher in PECs compare to non-PECs group. There was no hypoxia, hypotension or hypopnea in both groups. Conclusion Patients underwent CIEDs implantation procedure with PECs received lower sedation dosage and lower periprocedure pain score as compare to non-PECs group. Satisfaction score for both proceduralists and patients were trended higher in PECs group compare to non-PECs group. Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Changi General Hospital Research Grant