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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02450734
Other study ID # IMM CEPAR : 2012-014
Secondary ID
Status Completed
Phase N/A
First received May 19, 2015
Last updated May 20, 2015
Start date April 2011
Est. completion date May 2013

Study information

Verified date May 2015
Source Institut Mutualiste Montsouris
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing carotid endarterectomy

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound-guided intermediate cervical plexus block


Locations

Country Name City State
France Department of Anesthesia Institut Mutualiste Montsouris Paris

Sponsors (1)

Lead Sponsor Collaborator
Institut Mutualiste Montsouris

Country where clinical trial is conducted

France, 

References & Publications (3)

Choquet O, Dadure C, Capdevila X. Ultrasound-guided deep or intermediate cervical plexus block: the target should be the posterior cervical space. Anesth Analg. 2010 Dec;111(6):1563-4; author reply 1564-5. doi: 10.1213/ANE.0b013e3181f1d48f. — View Citation

Schechter MA, Shortell CK, Scarborough JE. Regional versus general anesthesia for carotid endarterectomy: the American College of Surgeons National Surgical Quality Improvement Program perspective. Surgery. 2012 Sep;152(3):309-14. doi: 10.1016/j.surg.2012 — View Citation

Usui Y, Kobayashi T, Kakinuma H, Watanabe K, Kitajima T, Matsuno K. An anatomical basis for blocking of the deep cervical plexus and cervical sympathetic tract using an ultrasound-guided technique. Anesth Analg. 2010 Mar 1;110(3):964-8. doi: 10.1213/ANE.0 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary quality of anesthesia assessed by the patient (quality scale) and absence of the need to general anesthesia immediate Yes
Secondary Hemodynamic stability measurements of non invasive arterial pressure and heart rate immediate during surgery Yes
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