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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator | 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 | Experimental | 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is inserted in-plane. 10 ml ropivacaine 4.75mg/ml are injected under ultrasound control, 5 ml injected when needle is withdrawn under ultrasound control, 5 ml in the subcutaneous plane. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided administration of ropivacaine 4.75 mg/ml | Other |
| ||
| landmark based superfical ropivacaine 4.75 mg/ml injection |
| Measure | Description | Time Frame |
|---|---|---|
| cervical block success | carotid artery endarterectomy performed under regional anaesthesia without supplemental topical lidocaine. | surgery time |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of conversion to general anaesthesia | conversion to general anaesthesia for insufficient analgesia | surgery time |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| amount of local anaesthesic used to performed the block |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascal Petit, MD | CHRU Besançon | Principal Investigator |
| Sebastien Pili-Floury, MD PhD | CHRU Besançon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier universitaire de Besançon | Besançon | 25000 | France |
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| Other |
|
| surgery time |
| regional anaesthesia-related complications | Horner syndrom, facial paralysis, cough, phrenic paralysis | 7 postoperative days |
| surgery related complications | hematoma, stroke, bleeding | 7 postoperative days |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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