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

Not Applicable

Completed

• Conditions: Carotid Atherosclerosis; Regional Anaesthesia Morbidity
• Interventions: Other: landmark based superfical ropivacaine 4.75 mg/ml injection; Other: Ultrasound-guided administration of ropivacaine 4.75 mg/ml

• Registration Number: NCT01742845
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-12
• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-03
• Last Update Submitted: 2012-12-03
• Study First Posted: 2012-12-06
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	landmark based superfical ropivacaine 4.75 mg/ml injection	landmark-based superficial cervical block is used. After insertion of the needle superficially below the skin, 20 to 30 ml of 4.75 mg/ml ropivacaine are injected fan-like in the subcutaneus plane.
echo group	Ultrasound-guided administration of ropivacaine 4.75 mg/ml	ultrasound-guided intermediate cervical block was performed. The probe is placed perpendicular to the skin, in the horizontal plane at the C3-C4 level. Needle is inserted in-plane. 10 ml ropivacaine 4.75mg/ml are injected under ultrasound control, 5 ml injected when needle is withdrawn under ultrasound control, 5 ml in the subcutaneous plane.

Primary Outcome Measures

Name	Time	Method
cervical block success	surgery time	carotid artery endarterectomy performed under regional anaesthesia without supplemental topical lidocaine.

Secondary Outcome Measures

Name	Time	Method
percentage of conversion to general anaesthesia	surgery time	conversion to general anaesthesia for insufficient analgesia

Trial Locations

Locations (1)

Centre Hospitalier universitaire de Besançon; 🇫🇷 Besançon, France