Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Surgery
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|ClinicalTrials.gov Identifier: NCT02450734|
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : May 21, 2015
Since stroke and myocardial ischemia are major causes of perioperative morbidity and mortality associated with carotid endarterectomy, monitoring the brain and ensuring the best hemodynamic stability are important goals of perioperative management.
The investigators conducted a prospective observational study about efficacy and safety of the ultrasound-guided intermediate cervical plexus block (CPB), with early (immediate postoperative) and mid-term (day 30) outcomes in awake patients undergoing carotid endarterectomy.
|Condition or disease||Intervention/treatment|
|Carotid Artery Stenosis||Procedure: Ultrasound-guided intermediate cervical plexus block|
From April 2011 to May 2013, all patients undergoing a carotid endarterectomy were informed of the study and prospectively included. The study was approved by our institutional ethical Review Board (CEPAR, Institut Mutualiste Montsouris Paris France). Oral consent was obtained from patients. Written informed consent of the patients to participate was not necessary according to the French law regarding observational study.
The anesthesiologist in charge of the patient recorded all the parameters of the ultrasound-guided intermediate cervical plexus block: facility and duration of block performance, local anesthetic volume, quality of anesthesia and surgical dissection, and adverse effects of the intermediate CPB. . Neurological status was assessed intraoperatively, in the postoperative setting and at one month after the procedure. Perioperative hemodynamic stability (intraoperative non invasive blood pressure variations) and pulse oxymetry were recorded. As well as ECG and cardiac Troponin I (cTnI) measurments performed the day before surgery and each morning during the 3 first postoperative days. Any clinical coronary or neurological event was recorded at one month.
Statistical analysis was performed on Prism 6 for Mac OS X (Version 6.0c, www.graphpad.com). Data are presented as mean ± standard deviation (SD) for continuous data and number (percentage) for categorical data.
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Safety and Efficiency of Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Surgery|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Realisation of an ultrasound-guided intermediate cervical plexus block for anesthesia of carotid endarterectomy
Procedure: Ultrasound-guided intermediate cervical plexus block
- quality of anesthesia [ Time Frame: immediate ]assessed by the patient (quality scale) and absence of the need to general anesthesia
- Hemodynamic stability [ Time Frame: immediate during surgery ]measurements of non invasive arterial pressure and heart rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450734
|Department of Anesthesia Institut Mutualiste Montsouris|
|Paris, France, 75014|
|Principal Investigator:||Isabelle LEBLANC, Doctor||Institut Mutualiste Montsouris|