Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Efficiency of Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Surgery

Conditions
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Carotid Artery Stenosis

Intervention / Treatment
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* Procedure: Ultrasound-guided intermediate cervical plexus block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing carotid endarterectomy Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carotid endarterectomy<br>Realisation of an ultrasound-guided intermediate cervical plexus block for anesthesia of carotid endarterectomy | Procedure: Ultrasound-guided intermediate cervical plexus block<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of anesthesia | assessed by the patient (quality scale) and absence of the need to general anesthesia | immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic stability | measurements of non invasive arterial pressure and heart rate | immediate during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound-guided intermediate cervical plexus block