Anterior Ultrasound-guided Cervical Plexus Block for Carotid Endarterectomy

Regional Anesthesia Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640613
• Other study ID #: 2012-A00147-36
• Status: Completed
• Phase: N/A
• First received: July 6, 2012
• Last updated: March 5, 2014
• Start date: April 2012
• Est. completion date: October 2013

Study information

• Verified date: March 2014
• Source: Hôpital Edouard Herriot
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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.

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...)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult

• carotid endarterectomy performed under regional anaesthesia

Exclusion Criteria:

• age < 18 years

• contralateral phrenic palsy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis
• Regional Anesthesia Morbidity

Locations

Country	Name	City	State
France	Departement of Anaesthesiology and Intensive Care, Edouard Heriot Hospital, HCL	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Edouard Herriot

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	conversion to general anaesthesia		surgery time	No
Secondary	amount of additional local anaesthetic	intraoperative supplementation by the surgeon	surgery time	No
Secondary	additional injection of remifentanil	In case of incontrolled pain : administration of remifentanil	surgery time	No
Secondary	complications	hoarseness, Horner syndrome, cough, facial palsy	anaesthesia time	No
Secondary	patient and surgeon satisfactions		after surgery	No
Secondary	additional injection of remifentanil	In case of uncontrolled pain : administration of remifentanil	surgery time	No