We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anterior Ultrasound-guided Cervical Plexus Block for Carotid Endarterectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01640613
First Posted: July 16, 2012
Last Update Posted: March 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Emmanuel Boselli, Hôpital Edouard Herriot
  Purpose

The aim of this study is to describe technique, efficiency, safety and satisfaction of ultrasound guided intermediate cervical plexus block for carotid endarterectomy.

The investigators present a simple approach for carotid regional anaesthesia by an anterior way that has not been published yet.


Condition
Carotid Atherosclerosis Regional Anesthesia Morbidity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anterior Approach Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomy

Resource links provided by NLM:


Further study details as provided by Emmanuel Boselli, Hôpital Edouard Herriot:

Primary Outcome Measures:
  • conversion to general anaesthesia [ Time Frame: surgery time ]

Secondary Outcome Measures:
  • amount of additional local anaesthetic [ Time Frame: surgery time ]
    intraoperative supplementation by the surgeon

  • additional injection of remifentanil [ Time Frame: surgery time ]
    In case of incontrolled pain : administration of remifentanil

  • complications [ Time Frame: anaesthesia time ]
    hoarseness, Horner syndrome, cough, facial palsy

  • patient and surgeon satisfactions [ Time Frame: after surgery ]
  • additional injection of remifentanil [ Time Frame: surgery time ]
    In case of uncontrolled pain : administration of remifentanil


Enrollment: 116
Study Start Date: April 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Detailed Description:
  • description of the anaesthetic procedure (duration, volume of anaesthetic local, efficiency)
  • realization of the surgery (pain, injection of anaesthetic local...)
  • post operative evaluation (pain, satisfaction...)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • adult
  • carotid endarterectomy performed under regional anaesthesia

Exclusion Criteria:

  • age < 18 years
  • contralateral phrenic palsy
  Contacts and Locations
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): NCT01640613


Locations
France
Departement of Anaesthesiology and Intensive Care, Edouard Heriot Hospital, HCL
Lyon, France, 69003
Sponsors and Collaborators
Hôpital Edouard Herriot
Investigators
Study Chair: Bernard Allaouchiche, MD PhD Edouard Heriot Hospital, HCL
Study Director: Emmanuel Boselli, MD PhD Edouard Heriot Hospital, HCL
Principal Investigator: Anne-Laure Calderon, MD Edouard Heriot Hospital, HCL
Principal Investigator: Cyrille Truc, MD Edouard Heriot Hospital, HCL
Principal Investigator: Julien Davidson, MD Edouard Heriot Hospital, HCL
Principal Investigator: Najia Rahali, MD Edouard Heriot Hospital, HCL
Principal Investigator: Farida Benatir, MD Edouard Heriot Hospital, HCL
  More Information

Responsible Party: Emmanuel Boselli, Md, PhD, Hôpital Edouard Herriot
ClinicalTrials.gov Identifier: NCT01640613     History of Changes
Other Study ID Numbers: 2012-A00147-36
First Submitted: July 6, 2012
First Posted: July 16, 2012
Last Update Posted: March 6, 2014
Last Verified: March 2014

Keywords provided by Emmanuel Boselli, Hôpital Edouard Herriot:
carotid endarterectomy
regional anaesthesia
ultrasound guided block

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