Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Surgery

Completed

• Conditions: Carotid Artery Stenosis
• Interventions: Procedure: Ultrasound-guided intermediate cervical plexus block

• Registration Number: NCT02450734
• Lead Sponsor: Institut Mutualiste Montsouris

Brief Summary

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

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 Timeline

• Study Start: 2011-04
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-05
• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-20
• Last Update Submitted: 2015-05-20
• Study First Posted: 2015-05-21
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients undergoing carotid endarterectomy

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carotid endarterectomy	Ultrasound-guided intermediate cervical plexus block	Realisation of an ultrasound-guided intermediate cervical plexus block for anesthesia of carotid endarterectomy

Primary Outcome Measures

Name	Time	Method
quality of anesthesia	immediate	assessed by the patient (quality scale) and absence of the need to general anesthesia

Secondary Outcome Measures

Name	Time	Method
Hemodynamic stability	immediate during surgery	measurements of non invasive arterial pressure and heart rate

Trial Locations

Locations (1)

Department of Anesthesia Institut Mutualiste Montsouris; 🇫🇷 Paris, France