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

NCT01742845 | Completed DMC

• 1 other identifier: P/2010/107
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carotid Atherosclerosis; Regional Anaesthesia Morbidity

Keywords

Ultrasound-guided; regional anaesthesia; Cervical block

Outcome Measures

Primary Outcomes (1)

• cervical block success

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

  surgery time

Secondary Outcomes (1)

• percentage of conversion to general anaesthesia

  surgery time

Other Outcomes (4)

• percentage of patient needing intraoperative systemic analgesia or sedation

  anaesthesia time

• amount of local anaesthesic used to performed the block

  surgery time

• regional anaesthesia-related complications

  7 postoperative days

Study Arms (2)

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.

Other: landmark based superfical ropivacaine 4.75 mg/ml injection

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is inserted in-plane. 10 ml ropivacaine 4.75mg/ml are injected under ultrasound control, 5 ml injected when needle is withdrawn under ultrasound control, 5 ml in the subcutaneous plane.

Other: Ultrasound-guided administration of ropivacaine 4.75 mg/ml

Interventions

Ultrasound-guided administration of ropivacaine 4.75 mg/ml OTHER

echo group

landmark based superfical ropivacaine 4.75 mg/ml injection OTHER

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient scheduled for elective carotid artery endarterectomy under regional anaesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Centre Hospitalier universitaire de Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Carotid Artery Diseases

Interventions

Injections

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Pascal Petit, MD

  CHRU Besançon

  PRINCIPAL INVESTIGATOR

• Sebastien Pili-Floury, MD PhD

  CHRU Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 6, 2012
• Study Start: April 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

FR (1)