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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • Centre Hospitalier Universitaire de Besançon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Pascal Petit, MD, CHRU Besançon; Principal Investigator: Sebastien Pili-Floury, MD PhD, CHRU Besançon

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: December 3, 2012
• First Submitted That Met QC Criteria: December 3, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Estimate): December 6, 2012
• Last Update Submitted That Met QC Criteria: December 3, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Ultrasound-guided; regional anaesthesia; Cervical block
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Carotid Artery Diseases; Atherosclerosis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: P/2010/107