Ultrasound-guided Intermediate Cervical Block Versus Superficial Cervical Block for Carotid Endarterectomy (CERVECHO) (CERVECHO)
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.
Regional Anaesthesia Morbidity
Other: Ultrasound-guided administration of ropivacaine 4.75 mg/ml
Other: landmark based superfical ropivacaine 4.75 mg/ml injection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Ultrasound-guided Intermediate Cervical Block Versus Superficial Cervical Block for Carotid : a Randomised Controlled Trial|
- cervical block success [ Time Frame: surgery time ] [ Designated as safety issue: No ]carotid artery endarterectomy performed under regional anaesthesia without supplemental topical lidocaine.
- percentage of conversion to general anaesthesia [ Time Frame: surgery time ] [ Designated as safety issue: No ]conversion to general anaesthesia for insufficient analgesia
- percentage of patient needing intraoperative systemic analgesia or sedation [ Time Frame: anaesthesia time ] [ Designated as safety issue: No ]if patient related pain in spite of supplemental local anaesthesic. sedation/analgesia let to the discretion of the anesthesist in the operating room
- amount of local anaesthesic used to performed the block [ Time Frame: surgery time ] [ Designated as safety issue: No ]
- regional anaesthesia-related complications [ Time Frame: 7 postoperative days ] [ Designated as safety issue: No ]Horner syndrom, facial paralysis, cough, phrenic paralysis
- surgery related complications [ Time Frame: 7 postoperative days ] [ Designated as safety issue: No ]hematoma, stroke, bleeding
|Study Start Date:||April 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Active Comparator: control group
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|
Experimental: echo group
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742845
|Centre Hospitalier universitaire de Besançon|
|Besançon, France, 25000|
|Principal Investigator:||Pascal Petit, MD||CHRU Besançon|
|Principal Investigator:||Sebastien Pili-Floury, MD PhD||CHRU Besançon|