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

Tracking Information

First Received Date ^ICMJE

July 6, 2012

Last Updated Date

February 3, 2013

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01640613 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Anterior Ultrasound-guided Cervical Plexus Block for Carotid Endarterectomy

Official Title ^ICMJE

Anterior Approach Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomy

Brief Summary

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.

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...)

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

patients undergoing carotid endarterectomy under regional anaesthesia

Condition ^ICMJE

Carotid Atherosclerosis
Regional Anesthesia Morbidity

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adult
carotid endarterectomy performed under regional anaesthesia

Exclusion Criteria:

age < 18 years
contralateral phrenic palsy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01640613

Other Study ID Numbers ^ICMJE

2012-A00147-36

Has Data Monitoring Committee

Responsible Party

Emmanuel Boselli, Hôpital Edouard Herriot

Study Sponsor ^ICMJE

Hôpital Edouard Herriot

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Hôpital Edouard Herriot

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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