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NCT Number: NCT01742845

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

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Key information

Conditions

Carotid Atherosclerosis Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Regional Anaesthesia Morbidity Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier universitaire de Besançon

Besançon, 25000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-guided administration of ropivacaine 4.75 mg/ml

Other

landmark based superfical ropivacaine 4.75 mg/ml injection

Other

Primary outcomes

  1. cervical block success

    Time frame: surgery time

    carotid artery endarterectomy performed under regional anaesthesia without supplemental topical lidocaine.

Secondary outcomes

  1. percentage of conversion to general anaesthesia

    Time frame: surgery time

    conversion to general anaesthesia for insufficient analgesia

Other outcomes

  1. percentage of patient needing intraoperative systemic analgesia or sedation

    Time frame: anaesthesia time

    if patient related pain in spite of supplemental local anaesthesic. sedation/analgesia let to the discretion of the anesthesist in the operating room

  2. amount of local anaesthesic used to performed the block

    Time frame: surgery time

  3. regional anaesthesia-related complications

    Time frame: 7 postoperative days

    Horner syndrom, facial paralysis, cough, phrenic paralysis

  4. surgery related complications

    Time frame: 7 postoperative days

    hematoma, stroke, bleeding

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: CERVECHO

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 6, 2012
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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