I65.2
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -age > 18 years -elective CEA surgery for treatment of ICA stenosis -written informed consent
Exclusion criteria
Exclusion criteria: -history of anaphylactic reaction to local anesthetics -local infection in the lateral cervical region -presumed limitation of patients' compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As primary outcome, plasma levels of ropivacaine were measured with high performance liquid chromatography before, 5, 10, 30, 60, and 180 min after the injection of ropivacaine. Plasma concentration of ropivacaine were analyzed with a high performance liquid chromatography photodiode array detection system (Agilent 1100 series, Agilent Technologies, Waldbronn, Germany). For quantification, drug-free serum was spiked at five different concentrations of ropivacaine (100, 200, 500, 1000, 2000 ng/ml). Ropivacaine concentration was calculated using linear regression. The limit of quantification of the method was 100 ng/ml. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints were anesthesia related nerve paralysis as well as satisfaction of patients and surgeons. The success of the blockade was evaluated 5, 10, 15 and 20 minutes after regional anesthesia by pin prick test in the dermatomes from C2 to C5. Additionally, 20 minutes after the block was performed, sensory skin testing at the hand, shoulder and motor testing at the wrist, arm and shoulder were performed. Puncture related complications, such as respiratory distress, hypoglossal and facial nerve palsy or Horner`s syndrome were also assessed 20 minutes after regional anesthesia. At the end of surgery, the surgeons assessed the surgical conditions on a subjective scale ranging from 1 to 5 (1-very good, 2-good, 3-reasonable, 4-poor, 5-very poor). All patients underwent follow-up visit on the first post-operative day. Patients were asked to assess their satisfaction with anesthesia in five grades from 1-very good, 2-good, 3-reasonable, 4-poor to 5-very poor and if they would again undergo surgery under regional anesthesia. | — |
Countries
Germany
Contacts
Universitätsklinikum Carl Gustav Carus Dresden Klinik und Poliklinik für Anästhesiologie und Intensivtherapie