Ultrasound-guided Intermediate Cervical Block Versus Superficial Cervical Block for Carotid Endarterectomy (CERVECHO)

Carotid Atherosclerosis Clinical Trial

— CERVECHO  

Official title:

Ultrasound-guided Intermediate Cervical Block Versus Superficial Cervical Block for Carotid : a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742845
• Other study ID #: P/2010/107
• Status: Completed
• Phase: N/A
• First received: December 3, 2012
• Last updated: December 3, 2012
• Start date: April 2011
• Est. completion date: March 2012

Study information

• Verified date: December 2012
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

The aim of this prospective, randomised, controlled study is to compare the efficacy of ultrasound-guided intermediate cervical block to superficial block for carotid endarterectomy.

Patients scheduled for carotide endarterectomy under regional anaesthesia (ropivacaine 4.75 mg/ml) are randomised into 2 groups according to the technique of anaesthesia performed: superficial cervical block (Control group) or, ultrasound guided intermediate cervical block (Echo group). Main outcome is cervical block success, defined by surgery performed under regional anaesthesia without supplemental topical lidocaine. Secondary outcomes are rate of conversion to general anaesthesia, total dose of supplemental topical lidocaine and block-related complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient scheduled for elective carotid artery endarterectomy under regional anaesthesia

Exclusion Criteria:

• indication for general anaesthesia

• known bleedind diathesis

• past medical allergy to local anaesthesic

• severe chronic pulmonary disease

• contralateral diaphragmatic motion abnormalities

• previous cervical ipsilateral surgery

• age < 18 years

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis
• Regional Anaesthesia Morbidity

Intervention

Other:
• Ultrasound-guided administration of ropivacaine 4.75 mg/ml

• landmark based superfical ropivacaine 4.75 mg/ml injection

Locations

Country	Name	City	State
France	Centre Hospitalier universitaire de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	percentage of patient needing intraoperative systemic analgesia or sedation	if patient related pain in spite of supplemental local anaesthesic. sedation/analgesia let to the discretion of the anesthesist in the operating room	anaesthesia time	No
Other	amount of local anaesthesic used to performed the block		surgery time	No
Other	regional anaesthesia-related complications	Horner syndrom, facial paralysis, cough, phrenic paralysis	7 postoperative days	No
Other	surgery related complications	hematoma, stroke, bleeding	7 postoperative days	No
Primary	cervical block success	carotid artery endarterectomy performed under regional anaesthesia without supplemental topical lidocaine.	surgery time	No
Secondary	percentage of conversion to general anaesthesia	conversion to general anaesthesia for insufficient analgesia	surgery time	No