LIDOCAINE HYDROCHLORIDE for Implantation of cardiac implantable electronic device (CIED)

Inclusion criteria

• {"criterion_text":"-Patients ≥ 18 years of age at time of consent"}
• {"criterion_text":"-Ability to understand and willingness to sign and date written informed consent document."}
• {"criterion_text":"-Female participants of childbearing potential may be enrolled in the trial if the participant fulfils all the following criteria: a.\tHas a negative high-sensitivity pregnancy test at Screening and on the day of the first dose (Day 1). b.\tIs not currently breastfeeding"}

Exclusion criteria

• {"criterion_text":"-Known intolerance to the IMP, auxiliary products or their components"}
• {"criterion_text":"-Current/planned simultaneous participation in another interventional trial"}
• {"criterion_text":"-Need for general anaesthesia"}
• {"criterion_text":"-Subcutaneously implanted CIED"}
• {"criterion_text":"-Opiate addiction and chronic pain patients"}
• {"criterion_text":"-BMI less than 18 or greater than 35 (body weight <50kg)"}
• {"criterion_text":"-Systemic infections"}
• {"criterion_text":"-Local inflammation in the area of the injection site"}
• {"criterion_text":"-Severe hepatic or renal insufficiency"}
• {"criterion_text":"-Psychiatric concomitant diseases, which are associated with an altered perception and assessment of pain"}

Primary endpoints

• {"endpoint_text":"-The difference in the Quality of Recovery 15 Score (QoR-15) assessed 24 hours after a subpectoral CIED","definition_or_measurement_approach":"Measured using the Quality of Recovery 15 Score (QoR-15) assessed 24 hours after subpectoral CIED implantation; a patient-centred assessment of perioperative recovery."}

Secondary endpoints

• {"endpoint_text":"-intraoperative additional local anaesthetic administration","definition_or_measurement_approach":"Recorded number and/or occurrence of additional local anaesthetic administrations during the procedure."}
• {"endpoint_text":"-postoperative analgesic consumption","definition_or_measurement_approach":"Measured as amount and/or type of postoperative analgesics consumed (e.g., cumulative dose)."}
• {"endpoint_text":"-the need and dose of additional analgesia","definition_or_measurement_approach":"Assessed by requirement for additional analgesia and doses administered."}
• {"endpoint_text":"-VAS after 2, 4, 6, 12, and 24 hours","definition_or_measurement_approach":"Pain intensity measured by Visual Analogue Scale (VAS) at specified time points postoperatively (2, 4, 6, 12, 24 hours)."}
• {"endpoint_text":"-VAS-AUC and VAS groups < 30 mm / 30 - 60 mm / > 60 m","definition_or_measurement_approach":"Area under the curve (AUC) of VAS over time and categorical grouping of VAS scores into <30 mm, 30-60 mm, and >60 mm."}
• {"endpoint_text":"-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","definition_or_measurement_approach":"Collection of clinical data: hemodynamic parameters, durations (anaesthesia and intervention), ICU admission occurrence, perioperative biomarker values (creatinine, troponin), and hospital length of stay."}
• {"endpoint_text":"-Changes in NYHA stage, LV-EF, and BMI","definition_or_measurement_approach":"Assessment of changes from baseline in NYHA functional class, left ventricular ejection fraction (LV-EF), and body mass index (BMI)."}
• {"endpoint_text":"-QoR-15 at 2 hours after CIED-implantation","definition_or_measurement_approach":"Quality of Recovery 15 Score assessed at 2 hours post-implantation."}
• {"endpoint_text":"-Linear evolution of QoR-15","definition_or_measurement_approach":"Analysis of QoR-15 scores over time to evaluate linear trend or evolution."}

Austria

Earliest CTIS Part Ii Submission Date

21-08-2024

Latest Decision Or Authorization Date

20-09-2024

Processing Time Days

30

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

Medizinische Universitaet Innsbruck

Organisation Type

Educational Institution

Country Of Registered Address

Austria