Text Size
Trial record 11 of 88 for:    carotid endarterectomy
Previous Study | Return to List | Next Study

Anterior Ultrasound-guided Cervical Plexus Block for Carotid Endarterectomy

This study is currently recruiting participants.
Verified February 2013 by Hôpital Edouard Herriot
Sponsor:
Information provided by (Responsible Party):
Emmanuel Boselli, Hôpital Edouard Herriot
ClinicalTrials.gov Identifier:
NCT01640613
First received: July 6, 2012
Last updated: February 3, 2013
Last verified: February 2013
History of Changes
  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:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Further study details as provided by Hôpital Edouard Herriot:

Primary Outcome Measures:
  • conversion to general anaesthesia [ Time Frame: surgery time ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • amount of additional local anaesthetic [ Time Frame: surgery time ] [ Designated as safety issue: No ]
    intraoperative supplementation by the surgeon

  • additional injection of remifentanil [ Time Frame: surgery time ] [ Designated as safety issue: No ]
    In case of incontrolled pain : administration of remifentanil

  • complications [ Time Frame: anaesthesia time ] [ Designated as safety issue: No ]
    hoarseness, Horner syndrome, cough, facial palsy

  • patient and surgeon satisfactions [ Time Frame: after surgery ] [ Designated as safety issue: No ]
  • additional injection of remifentanil [ Time Frame: surgery time ] [ Designated as safety issue: No ]
    In case of uncontrolled pain : administration of remifentanil


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01640613

Contacts
Contact: Emmanuel Boselli, MD PhD +33 (0)4 72 11 69 88 emmanuel.boselli@chu-lyon.fr
Contact: Anne-Laure Calderon, MD +33 (0)4 72 11 69 88 annelaure.calderon@gmail.com

Locations
France
Departement of Anaesthesiology and Intensive Care, Edouard Heriot Hospital, HCL Recruiting
Lyon, France, 69003
Contact: Emmanuel Boselli, MD, PhD     +33 (0)4 72 11 69 88     emmanuel.boselli@chu-lyon.fr    
Contact: Anne-Laure Calderon, MD     +33 (0)4 72 11 69 88     annelaure.calderon@gmail.com    
Principal Investigator: Emmanuel Boselli, MD PhD            
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

No publications provided

Responsible Party: Emmanuel Boselli, Md, PhD, Hôpital Edouard Herriot
ClinicalTrials.gov Identifier: NCT01640613     History of Changes
Other Study ID Numbers: 2012-A00147-36
Study First Received: July 6, 2012
Last Updated: February 3, 2013
Health Authority: France: L’Agence nationale de sécurité du médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by 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

ClinicalTrials.gov processed this record on May 16, 2013