MedDataX Logo

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

NCT ID: NCT01742845

Last Updated: 2012-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carotid Atherosclerosis Regional Anaesthesia Morbidity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Ultrasound-guided regional anaesthesia Cervical block

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

landmark based superfical ropivacaine 4.75 mg/ml injection

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Ultrasound-guided administration of ropivacaine 4.75 mg/ml

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound-guided administration of ropivacaine 4.75 mg/ml

Intervention Type OTHER

landmark based superfical ropivacaine 4.75 mg/ml injection

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pascal Petit, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Besançon

Sebastien Pili-Floury, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU Besançon

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier universitaire de Besançon

Besançon, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P/2010/107

Identifier Type: -

Identifier Source: org_study_id