None listed
Conditions
Brief summary
This randomized, double-blind controlled trial aims to evaluate the analgesic efficacy and safety of adjunctive esketamine added to a superficial cervical plexus block in patients undergoing carotid endarterectomy. Participants will be randomly assigned to receive either a local anesthetic solution with esketamine or a local anesthetic solution alone. The primary outcome is time to first postoperative rescue analgesic administration. Secondary outcomes include postoperative pain intensity assessed using the Numerical Pain Rating Scale, total postoperative analgesic consumption, and the incidence of esketamine-related adverse effects, including dissociative symptoms assessed with the Clinician-Administered Dissociative States Scale (CADSS-6). The study has received approval from the institutional ethics committee.
Interventions
Intervention group:
Ultrasound-guided superficial cervical plexus block performed using perineural injection of 0,5% levobupivacaine (2mg/kg) with the addition of esketamine 25 mg as an adjuvant. The study solution is prepared by an anesthesiologist not involved in patient care or data collection. The block is performed under ultrasound guidance prior to elective carotid endarterectomy. Correct needle placement and local anesthetic spread are confirmed by ultrasound visualization. All procedure
Intervention group: Ultrasound-guided superficial cervical plexus block performed using perineural injection of 0,5% levobupivacaine (2mg/kg) with the addition of esketamine 25 mg as an adjuvant. The study solution is prepared by an anesthesiologist not involved in patient care or data collection. The block is performed under ultrasound guidance prior to elective carotid endarterectomy. Correct needle placement and local anesthetic spread are confirmed by ultrasound visualization. All procedures are performed by experienced anesthesiologists. Administration details are documented in anesthesia records and study documentation. Adherence to the intervention protocol is verified by review of medical records
Sponsors
Sestre Milosrdnice University Hospital Center
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients (ASA physical status II-III) scheduled for elective carotid endarterectomy under regional anesthesia with superficial cervical plexus block, able to communicate and provide written informed consent.
Exclusion criteria
Known allergy or hypersensitivity to esketamine of levobupovacaine; history of psychiatric disorders or cognitive impairment; inability to communicate or cooperate during the procedure; refusal or inability to provide informed consent.
Outcome results
None listed