Carotid AtherosclerosisNCT01640613
Anterior Ultrasound-guided Cervical Plexus Block for Carotid Endarterectomy
An observational study of Carotid Atherosclerosis and Regional Anesthesia Morbidity, run by Hôpital Edouard Herriot at 1 site in France.
Trial summary
The aim of this study is to describe technique, efficiency, safety and satisfaction of ultrasound guided intermediate cervical plexus block for carotid endarterectomy. The investigators present a simple approach for carotid regional anaesthesia by an anterior way that has not been published yet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Atherosclerosis, Regional Anesthesia Morbidity
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Oct 2013
- Phase
- Observational
- 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
Study population: patients undergoing carotid endarterectomy under regional anaesthesia
Who may be able to join
- adult
- carotid endarterectomy performed under regional anaesthesia
Who cannot join
- age < 18 years
- contralateral phrenic palsy
Trial locations and contacts
1 site in 1 country.
France1 site
Departement of Anaesthesiology and Intensive Care, Edouard Heriot Hospital, HCL
Lyon, 69003
About this study
Official title: Anterior Approach Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomy
The aim of this study is to describe technique, efficiency, safety and satisfaction of ultrasound guided intermediate cervical plexus block for carotid endarterectomy.
The investigators present a simple approach for carotid regional anaesthesia by an anterior way that has not been published yet.
Read the detailed description
- description of the anaesthetic procedure (duration, volume of anaesthetic local, efficiency)
- realization of the surgery (pain, injection of anaesthetic local...)
- post operative evaluation (pain, satisfaction...)
- Keywords
- carotid endarterectomy, regional anaesthesia, ultrasound guided block
- Medical subject headings
- Carotid Artery Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
conversion to general anaesthesia
Measured: surgery time
Secondary outcomes (5)
amount of additional local anaesthetic
intraoperative supplementation by the surgeon
Measured: surgery time
additional injection of remifentanil
In case of incontrolled pain : administration of remifentanil
Measured: surgery time
complications
hoarseness, Horner syndrome, cough, facial palsy
Measured: anaesthesia time
patient and surgeon satisfactions
Measured: after surgery
additional injection of remifentanil
In case of uncontrolled pain : administration of remifentanil
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 posted16 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2013
- Study completionOct 2013
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Edouard Herriot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanuel Boselli, Hôpital Edouard Herriot
- Investigators
- Bernard Allaouchiche, MD PhD, Study chair, Edouard Heriot Hospital, HCLEmmanuel Boselli, MD PhD, Study director, Edouard Heriot Hospital, HCLAnne-Laure Calderon, MD, Principal investigator, Edouard Heriot Hospital, HCLCyrille Truc, MD, Principal investigator, Edouard Heriot Hospital, HCLJulien Davidson, MD, Principal investigator, Edouard Heriot Hospital, HCLNajia Rahali, MD, Principal investigator, Edouard Heriot Hospital, HCLFarida Benatir, MD, Principal investigator, Edouard Heriot Hospital, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640613
- Sponsor's protocol ID
- 2012-A00147-36
- Status last verified
- Mar 2014
- First submitted
- 6 Jul 2012
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Approach Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT01640613
- Acronym / sponsor ID
- 2012-A00147-36
- Keywords
- carotid endarterectomy, regional anaesthesia, ultrasound guided block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Hôpital Edouard HerriotUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 16 Jul 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 study is to describe technique, efficiency, safety and satisfaction of ultrasound guided intermediate cervical plexus block for carotid endarterectomy.
The investigators present a simple approach for carotid regional anaesthesia by an anterior way that has not been published yet.
Detailed description
- description of the anaesthetic procedure (duration, volume of anaesthetic local, efficiency)
- realization of the surgery (pain, injection of anaesthetic local...)
- post operative evaluation (pain, satisfaction...)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing carotid endarterectomy under regional anaesthesia
Key inclusion criteria (2 listed)
- adult
- carotid endarterectomy performed under regional anaesthesia
Key exclusion criteria (2 listed)
- age < 18 years
- contralateral phrenic palsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
conversion to general anaesthesia
Time frame: surgery time
5 secondary outcomes
amount of additional local anaesthetic
Time frame: surgery time
additional injection of remifentanil
Time frame: surgery time
complications
Time frame: anaesthesia time
patient and surgeon satisfactions
Time frame: after surgery
additional injection of remifentanil
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 Mar 2014.
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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.
Bernard Allaouchiche, MD PhD study chair
Edouard Heriot Hospital, HCL
Emmanuel Boselli, MD PhD study director
Edouard Heriot Hospital, HCL
Anne-Laure Calderon, MD principal investigator
Edouard Heriot Hospital, HCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Atherosclerosis and Regional Anesthesia Morbidity, run by Hôpital Edouard Herriot 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 2 inclusion and 2 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 Mar 2014. 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?
conversion to general anaesthesia (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 Mar 2014.