Carotid AtherosclerosisCERVECHONCT01742845
Ultrasound-guided Intermediate Cervical Block Versus Superficial Cervical Block for Carotid Endarterectomy (CERVECHO)
A study testing Ultrasound-guided administration of ropivacaine 4.75 mg/ml and landmark based superfical ropivacaine 4.75 mg/ml injection in people with Carotid Atherosclerosis and Regional Anaesthesia Morbidity, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Atherosclerosis, Regional Anaesthesia Morbidity
- What is being tested?
- Ultrasound-guided administration of ropivacaine 4.75 mg/ml and landmark based superfical ropivacaine 4.75 mg/ml injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient scheduled for elective carotid artery endarterectomy under regional anaesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Intermediate Cervical Block Versus Superficial Cervical Block for Carotid : a Randomised Controlled Trial
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.
- Being tested
- Ultrasound-guided administration of ropivacaine 4.75 mg/ml, landmark based superfical ropivacaine 4.75 mg/ml injection
- Keywords
- Ultrasound-guided, regional anaesthesia, Cervical block
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided administration of ropivacaine 4.75 mg/mlOther
landmark based superfical ropivacaine 4.75 mg/ml injectionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Ultrasound-guided administration of ropivacaine 4.75 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical block success
carotid artery endarterectomy performed under regional anaesthesia without supplemental topical lidocaine.
Measured: surgery time
Secondary outcomes (1)
percentage of conversion to general anaesthesia
conversion to general anaesthesia for insufficient analgesia
Measured: surgery time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Petit, MD, Principal investigator, CHRU BesançonSebastien Pili-Floury, MD PhD, Principal investigator, CHRU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742845
- Sponsor's protocol ID
- P/2010/107
- Acronym
- CERVECHO
- Status last verified
- Dec 2012
- First submitted
- 3 Dec 2012
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Intermediate Cervical Block Versus Superficial Cervical Block for Carotid : a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01742845
- Acronym / sponsor ID
- CERVECHO / P/2010/107
- Keywords
- Ultrasound-guided, regional anaesthesia, Cervical block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: landmark based superfical ropivacaine 4.75 mg/ml injectionlandmark-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. |
| echo group | Experimental | Other: Ultrasound-guided administration of ropivacaine 4.75 mg/mlultrasound-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient scheduled for elective carotid artery endarterectomy under regional anaesthesia
Key exclusion criteria (7 listed)
- indication for general anaesthesia
- known bleedind diathesis
- past medical allergy to local anaesthesic
- severe chronic pulmonary disease
- contralateral diaphragmatic motion abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided administration of ropivacaine 4.75 mg/ml | Other | echo group |
| landmark based superfical ropivacaine 4.75 mg/ml injection | Other | control group |
Primary outcome
cervical block success
Time frame: surgery time
carotid artery endarterectomy performed under regional anaesthesia without supplemental topical lidocaine.
1 secondary outcome
percentage of conversion to general anaesthesia
Time frame: surgery time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Petit, MD principal investigator
CHRU Besançon
Sebastien Pili-Floury, MD PhD principal investigator
CHRU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided administration of ropivacaine 4.75 mg/ml and landmark based superfical ropivacaine 4.75 mg/ml injection in people with Carotid Atherosclerosis and Regional Anaesthesia Morbidity, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cervical block success (time frame: surgery time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2012.