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Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02450734
Enrollment
50
Registered
2015-05-21
Start date
2011-04-30
Completion date
2013-05-31
Last updated
2015-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Artery Stenosis

Keywords

ultrasound-guided intermediate cervical plexus block

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.

Interventions

Sponsors

Institut Mutualiste Montsouris
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing carotid endarterectomy

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
quality of anesthesiaimmediateassessed by the patient (quality scale) and absence of the need to general anesthesia

Secondary

MeasureTime frameDescription
Hemodynamic stabilityimmediate during surgerymeasurements of non invasive arterial pressure and heart rate

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026