- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01640613
Anterior Ultrasound-guided Cervical Plexus Block for Carotid Endarterectomy
March 5, 2014 updated by: Emmanuel Boselli, Hôpital Edouard Herriot
Anterior Approach Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomy
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.
Study Overview
Status
Completed
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
Observational
Enrollment (Actual)
116
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Lyon, France, 69003
- Departement of Anaesthesiology and Intensive Care, Edouard Heriot Hospital, HCL
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients undergoing carotid endarterectomy under regional anaesthesia
Description
Inclusion Criteria:
- adult
- carotid endarterectomy performed under regional anaesthesia
Exclusion Criteria:
- age < 18 years
- contralateral phrenic palsy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
conversion to general anaesthesia
Time Frame: surgery time
|
surgery time
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
amount of additional local anaesthetic
Time Frame: surgery time
|
intraoperative supplementation by the surgeon
|
surgery time
|
|
additional injection of remifentanil
Time Frame: surgery time
|
In case of incontrolled pain : administration of remifentanil
|
surgery time
|
|
complications
Time Frame: anaesthesia time
|
hoarseness, Horner syndrome, cough, facial palsy
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anaesthesia time
|
|
patient and surgeon satisfactions
Time Frame: after surgery
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after surgery
|
|
|
additional injection of remifentanil
Time Frame: surgery time
|
In case of uncontrolled pain : administration of remifentanil
|
surgery time
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
July 6, 2012
First Submitted That Met QC Criteria
July 12, 2012
First Posted (Estimate)
July 16, 2012
Study Record Updates
Last Update Posted (Estimate)
March 6, 2014
Last Update Submitted That Met QC Criteria
March 5, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-A00147-36
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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