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

Study Overview
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Brief Summary
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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.

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

Conditions
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Carotid Atherosclerosis, Regional Anaesthesia Morbidity

Intervention / Treatment
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* Other: Ultrasound-guided administration of ropivacaine 4.75 mg/ml
* Other: landmark based superfical ropivacaine 4.75 mg/ml injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>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. | Other: landmark based superfical ropivacaine 4.75 mg/ml injection<br> <br> |
| Experimental: echo group<br>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. | Other: Ultrasound-guided administration of ropivacaine 4.75 mg/ml<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cervical block success | carotid artery endarterectomy performed under regional anaesthesia without supplemental topical lidocaine. | surgery time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of conversion to general anaesthesia | conversion to general anaesthesia for insufficient analgesia | surgery time | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound-guided, regional anaesthesia, Cervical block