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

Primary Purpose

Carotid Atherosclerosis, Regional Anaesthesia Morbidity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound-guided administration of ropivacaine 4.75 mg/ml
landmark based superfical ropivacaine 4.75 mg/ml injection
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Carotid Atherosclerosis focused on measuring Ultrasound-guided, regional anaesthesia, Cervical block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier universitaire de Besançon

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

echo group

Arm Description

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.

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is inserted in-plane. 10 ml ropivacaine 4.75mg/ml are injected under ultrasound control, 5 ml injected when needle is withdrawn under ultrasound control, 5 ml in the subcutaneous plane.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

percentage of conversion to general anaesthesia
conversion to general anaesthesia for insufficient analgesia

Full Information

First Posted
December 3, 2012
Last Updated
December 3, 2012
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT01742845
Brief Title
Ultrasound-guided Intermediate Cervical Block Versus Superficial Cervical Block for Carotid Endarterectomy (CERVECHO)
Acronym
CERVECHO
Official Title
Ultrasound-guided Intermediate Cervical Block Versus Superficial Cervical Block for Carotid : a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Atherosclerosis, Regional Anaesthesia Morbidity
Keywords
Ultrasound-guided, regional anaesthesia, Cervical block

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
echo group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Ultrasound-guided administration of ropivacaine 4.75 mg/ml
Intervention Type
Other
Intervention Name(s)
landmark based superfical ropivacaine 4.75 mg/ml injection
Primary Outcome Measure Information:
Title
cervical block success
Description
carotid artery endarterectomy performed under regional anaesthesia without supplemental topical lidocaine.
Time Frame
surgery time
Secondary Outcome Measure Information:
Title
percentage of conversion to general anaesthesia
Description
conversion to general anaesthesia for insufficient analgesia
Time Frame
surgery time
Other Pre-specified Outcome Measures:
Title
percentage of patient needing intraoperative systemic analgesia or sedation
Description
if patient related pain in spite of supplemental local anaesthesic. sedation/analgesia let to the discretion of the anesthesist in the operating room
Time Frame
anaesthesia time
Title
amount of local anaesthesic used to performed the block
Time Frame
surgery time
Title
regional anaesthesia-related complications
Description
Horner syndrom, facial paralysis, cough, phrenic paralysis
Time Frame
7 postoperative days
Title
surgery related complications
Description
hematoma, stroke, bleeding
Time Frame
7 postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Petit, MD
Organizational Affiliation
CHRU Besançon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sebastien Pili-Floury, MD PhD
Organizational Affiliation
CHRU Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier universitaire de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France

12. IPD Sharing Statement

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

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