Comparison of local anaesthesia and regional anaesthesia (PECS II block) 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

Conditions

Need for a subpectoral implantation of cardiac implantable electronic devices (CIEDs)

Brief summary

The difference in the Quality of Recovery 15 Score (QoR-15) assessed 24 hours after a subpectoral CIED

Detailed description

intraoperative additional local anaesthetic administration, postoperative analgesic consumption, the need and dose of additional analgesia, VAS after 2, 4, 6, 12, and 24 hours, VAS-AUC and VAS groups < 30 mm / 30 - 60 mm / > 60 m, Data regarding hemodynamic stability, the duration of anaesthesia and intervention, any ICU stay, perioperative course of biomarkers (creatinine and troponin), and hospital length of stay, Changes in NYHA stage, LV-EF, and BMI, QoR-15 at 2 hours after CIED-implantation, Linear evolution of QoR-15

Wallner B, Stundner O, Gasteiger E, Mittermayr M, Fiala A, Hollmann MW, Gasser S, Stastny L, Gasteiger L.

2025-12-17

10.1186/s13063-025-09362-z

Interventions

DRUGXylanaest purum 1 % - Durchstechflaschen

DRUGRopivacainhydrochlorid Sintetica 2 mg/ml Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The difference in the Quality of Recovery 15 Score (QoR-15) assessed 24 hours after a subpectoral CIED	—

Secondary

Measure	Time frame
intraoperative additional local anaesthetic administration, postoperative analgesic consumption, the need and dose of additional analgesia, VAS after 2, 4, 6, 12, and 24 hours, VAS-AUC and VAS groups < 30 mm / 30 - 60 mm / > 60 m, Data regarding hemodynamic stability, the duration of anaesthesia and intervention, any ICU stay, perioperative course of biomarkers (creatinine and troponin), and hospital length of stay, Changes in NYHA stage, LV-EF, and BMI, QoR-15 at 2 hours after CIED-implantation, Linear evolution of QoR-15	—

Measure

Time frame

intraoperative additional local anaesthetic administration, postoperative analgesic consumption, the need and dose of additional analgesia, VAS after 2, 4, 6, 12, and 24 hours, VAS-AUC and VAS groups < 30 mm / 30 - 60 mm / > 60 m, Data regarding hemodynamic stability, the duration of anaesthesia and intervention, any ICU stay, perioperative course of biomarkers (creatinine and troponin), and hospital length of stay, Changes in NYHA stage, LV-EF, and BMI, QoR-15 at 2 hours after CIED-implantation, Linear evolution of QoR-15

—

Countries

Austria

Outcome results

None listed