None listed
Conditions
Brief summary
This study compares two local anesthetic combinations used in superficial cervical block (SCB) during carotid endarterectomy (CEA). The hypothesis is that ropivacaine with lidocaine provides faster onset and longer sensory block than levobupivacaine with lidocaine, with similar safety. Participants will be randomly assigned to one of the two anesthetic protocols. The study will measure onset time, duration of block, and postoperative pain. The aim is to improve anesthesia quality and patient outcomes during CEA.
Interventions
The intervention under investigation consists of a superficial cervical block (SCB) administered using a combination of two local anesthetics. In the experimental group, ropivacaine is administered at a dose of 2 mg/kg combined with lidocaine at a fixed dose of 200 mg. The SCB is performed following sterile preparation of the neck, targeting predefined anatomical landmarks. A 25G Quincke spinal needle is used to infiltrate 15 mL of the anesthetic mixture at a depth of 1 cm at the lateral site of the neck in the middle of the posterior border of the sternocleidomastoid muscle (SCM) to anesthetize the superficial cervical plexus and carotid artery. The remainder of the anesthetic mixture is administered subcutaneously along the entire posterior border of the SCM, as well as along the mandibular border and interclavicular region. Adherence to the intervention is ensured through the use of a standardized protocol specifying anatomical landmarks, injection volumes, and depth. All blocks are performed by an experienced anesthesiologist (10 years of practice). Continuous monitoring of vital signs confirms proper administration, and the time to onset and duration of the sensory block are recorded for each participant. Any deviations from the protocol are documented and addressed according to study guidelines. The intervention is delivered in a surgical setting with continuous invasive blood pressure monitoring established via radial artery cannulation. Time to onset and total duration of the sensory block are measured, and pain levels are assessed every two hours for 12 hours post-block using the Numeric Pain Rating Scale (NPRS).
Sponsors
Study design
Eligibility
Inclusion criteria
Participants scheduled for elective carotid endarterectomy under regional anesthesia with a superficial cervical block. Eligibility includes confirmed significant stenosis of the internal carotid artery. Participants need to be capable of understanding the study procedures and providing written informed consent.
Exclusion criteria
Patients with known allergies to the study drugs or with infection at the injection site will be excluded. Patients unable to provide informed consent will also be excluded.