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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT01742845
First received: December 3, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Carotid Atherosclerosis
Regional Anaesthesia Morbidity
Other: Ultrasound-guided administration of ropivacaine 4.75 mg/ml
Other: landmark based superfical ropivacaine 4.75 mg/ml injection

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • cervical block success [ Time Frame: surgery time ] [ Designated as safety issue: No ]
    carotid artery endarterectomy performed under regional anaesthesia without supplemental topical lidocaine.


Secondary Outcome Measures:
  • percentage of conversion to general anaesthesia [ Time Frame: surgery time ] [ Designated as safety issue: No ]
    conversion to general anaesthesia for insufficient analgesia


Other Outcome Measures:
  • 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


Enrollment: 86
Study Start Date: April 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742845

Locations
France
Centre Hospitalier universitaire de Besançon
Besançon, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Principal Investigator: Pascal Petit, MD CHRU Besançon
Principal Investigator: Sebastien Pili-Floury, MD PhD CHRU Besançon
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01742845     History of Changes
Other Study ID Numbers: P/2010/107
Study First Received: December 3, 2012
Last Updated: December 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Besancon:
Ultrasound-guided
regional anaesthesia
Cervical block

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Carotid Artery Diseases
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014