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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Carotid Artery Stenosis Procedure: Ultrasound-guided intermediate cervical plexus block

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.


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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
Carotid endarterectomy
Realisation of an ultrasound-guided intermediate cervical plexus block for anesthesia of carotid endarterectomy
Procedure: Ultrasound-guided intermediate cervical plexus block



Primary Outcome Measures :
  1. quality of anesthesia [ Time Frame: immediate ]
    assessed by the patient (quality scale) and absence of the need to general anesthesia


Secondary Outcome Measures :
  1. Hemodynamic stability [ Time Frame: immediate during surgery ]
    measurements of non invasive arterial pressure and heart rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing carotid endarterectomy
Criteria

Inclusion Criteria:

  • Patients undergoing carotid endarterectomy

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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


Locations
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France
Department of Anesthesia Institut Mutualiste Montsouris
Paris, France, 75014
Sponsors and Collaborators
Institut Mutualiste Montsouris
Investigators
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Principal Investigator: Isabelle LEBLANC, Doctor Institut Mutualiste Montsouris

Publications of Results:
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Responsible Party: Institut Mutualiste Montsouris
ClinicalTrials.gov Identifier: NCT02450734     History of Changes
Other Study ID Numbers: IMM CEPAR : 2012-014
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015

Keywords provided by Institut Mutualiste Montsouris:
ultrasound-guided intermediate cervical plexus block

Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases