Comparison of local anaesthesia and regional anaesthesia (PSP/IPP) on QoR-15 in patients undergoing subpectoral implantation of cardiac implantable electronic devices (CIEDs)—a prospective, randomized, double-blinded, controlled pragmatic trial with two arms

BACKGROUND: The implantation of cardiac implantable electronic devices (CIED) is the treatment of choice for the prevention of sudden cardiac deaths in high-risk patients. Given the comorbidities, this superficial surgical intervention is mostly performed in local anaesthesia. Triggered by the upcoming opioid crisis, the burden of postsurgical pain has gained popularity, as adequate perioperative pain management is a cornerstone in the prevention of persistent opioid use. Aim of this study is to assess the perioperative pain management of local anaesthesia versus pectoserratus plain/interpectoral plain (PSP/IPP) block for submuscular CIED implantation. METHODS: In a single-centre, prospective, single-blinded, two-group randomized trial, 80 patients undergoing submuscular CIED implantation will be randomized to receive a PSP/IPP with ropivacaine 0.375% (intervention group) or a LA with lidocaine 2% (control group). The primary outcome is the Quality of Recovery-15 (QoR-15) assessed 24 h after surgery. Secondary endpoints include the intraoperative additional LA administration; the postoperative analgesic consumption; the need and dose of additional analgesia; Visual Analogue Scale (VAS) after 2, 4, 6, 12, and 24 h; and VAS-AUC and VAS groups <30 mm/30-60 mm/>60 mm. DISCUSSION: This prospective, randomized, controlled, and single-blinded trial aims to assess if a PSP/IPP with ropivacaine affects the postoperative QoR-15 score compared to a conventional local anaesthesia with lidocaine in patients undergoing submuscular CIED implantation. Given the impressively high rate of persistent opioid use (POU) in patients after CIED, results from this study could help improve the perioperative pain management. TRIAL REGISTRATION: EUDRA CT Number: 2023-508997-27. Registered on 20 September 2024. https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2023-508997-27-00 .