Carotid Artery StenosisNCT02450734
Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Surgery
An observational study of Carotid Artery Stenosis, run by Institut Mutualiste Montsouris at 1 site in France.
Trial summary
Since stroke and myocardial ischemia are major causes of perioperative morbidity and mortality associated with carotid endarterectomy, monitoring the brain and ensuring the best hemodynamic stability are important goals of perioperative management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Ultrasound-guided intermediate cervical plexus block
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to May 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
Who may be able to join
- Patients undergoing carotid endarterectomy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Anesthesia Institut Mutualiste Montsouris
Paris, Paris, 75014
About this study
Official title: Safety and Efficiency of Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Surgery
Since stroke and myocardial ischemia are major causes of perioperative morbidity and mortality associated with carotid endarterectomy, monitoring the brain and ensuring the best hemodynamic stability are important goals of perioperative management.
The investigators conducted a prospective observational study about efficacy and safety of the ultrasound-guided intermediate cervical plexus block (CPB), with early (immediate postoperative) and mid-term (day 30) outcomes in awake patients undergoing carotid endarterectomy.
Read the detailed description
From April 2011 to May 2013, all patients undergoing a carotid endarterectomy were informed of the study and prospectively included. The study was approved by our institutional ethical Review Board (CEPAR, Institut Mutualiste Montsouris Paris France). Oral consent was obtained from patients. Written informed consent of the patients to participate was not necessary according to the French law regarding observational study.
The anesthesiologist in charge of the patient recorded all the parameters of the ultrasound-guided intermediate cervical plexus block: facility and duration of block performance, local anesthetic volume, quality of anesthesia and surgical dissection, and adverse effects of the intermediate CPB. . Neurological status was assessed intraoperatively, in the postoperative setting and at one month after the procedure. Perioperative hemodynamic stability (intraoperative non invasive blood pressure variations) and pulse oxymetry were recorded. As well as ECG and cardiac Troponin I (cTnI) measurments performed the day before surgery and each morning during the 3 first postoperative days. Any clinical coronary or neurological event was recorded at one month.
Statistical analysis was performed on Prism 6 for Mac OS X (Version 6.0c, www.graphpad.com). Data are presented as mean ± standard deviation (SD) for continuous data and number (percentage) for categorical data.
- Conditions
- Carotid Artery Stenosis
- Being tested
- Ultrasound-guided intermediate cervical plexus block
- Keywords
- ultrasound-guided intermediate cervical plexus block
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided intermediate cervical plexus blockProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Carotid endarterectomy | Realisation of an ultrasound-guided intermediate cervical plexus block for anesthesia of carotid endarterectomy Receives: Procedure: Ultrasound-guided intermediate cervical plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of anesthesia
assessed by the patient (quality scale) and absence of the need to general anesthesia
Measured: immediate
Secondary outcomes (1)
Hemodynamic stability
measurements of non invasive arterial pressure and heart rate
Measured: immediate during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startApr 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery StenosisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle LEBLANC, Doctor, Principal investigator, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450734
- Sponsor's protocol ID
- IMM CEPAR : 2012-014
- Status last verified
- May 2015
- First submitted
- 19 May 2015
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Schechter MA, Shortell CK, Scarborough JE. Regional versus general anesthesia for carotid endarterectomy: the American College of Surgeons National Surgical Quality Improvement Program perspective. Surgery. 2012 Sep;152(3):309-14. doi: 10.1016/j.surg.2012.05.008. Epub 2012 Jun 27.
PubMed 22749369Usui Y, Kobayashi T, Kakinuma H, Watanabe K, Kitajima T, Matsuno K. An anatomical basis for blocking of the deep cervical plexus and cervical sympathetic tract using an ultrasound-guided technique. Anesth Analg. 2010 Mar 1;110(3):964-8. doi: 10.1213/ANE.0b013e3181c91ea0. Epub 2009 Dec 15.
PubMed 20008914Choquet O, Dadure C, Capdevila X. Ultrasound-guided deep or intermediate cervical plexus block: the target should be the posterior cervical space. Anesth Analg. 2010 Dec;111(6):1563-4; author reply 1564-5. doi: 10.1213/ANE.0b013e3181f1d48f. No abstract available.
PubMed 21106978
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficiency of Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Surgery
- ClinicalTrials.gov ID
- NCT02450734
- Acronym / sponsor ID
- IMM CEPAR : 2012-014
- Conditions
- Carotid Artery Stenosis
- Keywords
- ultrasound-guided intermediate cervical plexus block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 May 2015 (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.
Since stroke and myocardial ischemia are major causes of perioperative morbidity and mortality associated with carotid endarterectomy, monitoring the brain and ensuring the best hemodynamic stability are important goals of perioperative management.
The investigators conducted a prospective observational study about efficacy and safety of the ultrasound-guided intermediate cervical plexus block (CPB), with early (immediate postoperative) and mid-term (day 30) outcomes in awake patients undergoing carotid endarterectomy.
Detailed description
From April 2011 to May 2013, all patients undergoing a carotid endarterectomy were informed of the study and prospectively included. The study was approved by our institutional ethical Review Board (CEPAR, Institut Mutualiste Montsouris Paris France). Oral consent was obtained from patients. Written informed consent of the patients to participate was not necessary according to the French law regarding observational study.
The anesthesiologist in charge of the patient recorded all the parameters of the ultrasound-guided intermediate cervical plexus block: facility and duration of block performance, local anesthetic volume, quality of anesthesia and surgical dissection, and adverse effects of the intermediate CPB. . Neurological status was assessed intraoperatively, in the postoperative setting and at one month after the procedure. Perioperative hemodynamic stability (intraoperative non invasive blood pressure variations) and pulse oxymetry were recorded. As well as ECG and cardiac Troponin I (cTnI) measurments performed the day before surgery and each morning during the 3 first postoperative days. Any clinical coronary or neurological event was recorded at one month.
Statistical analysis was performed on Prism 6 for Mac OS X (Version 6.0c, www.graphpad.com). Data are presented as mean ± standard deviation (SD) for continuous data and number (percentage) for categorical data.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid endarterectomy | – | Procedure: Ultrasound-guided intermediate cervical plexus blockRealisation of an ultrasound-guided intermediate cervical plexus block for anesthesia of carotid endarterectomy |
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
Key inclusion criteria (1 listed)
- Patients undergoing carotid endarterectomy
Key exclusion criteria (1 listed)
- None
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 intermediate cervical plexus block | Procedure or surgery | Carotid endarterectomy |
Primary outcome
quality of anesthesia
Time frame: immediate
assessed by the patient (quality scale) and absence of the need to general anesthesia
1 secondary outcome
Hemodynamic stability
Time frame: immediate during surgery
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 21 May 2015.
- Results publication: PubMed 22749369Schechter MA, Shortell CK, Scarborough JE. Regional versus general anesthesia for carotid endarterectomy: the American College of Surgeons National Surgical Quality Improvement Program perspective. Surgery. 2012 Sep;152(3):309-14. doi: 10.1016/j.surg.2012.05.008. Epub 2012 Jun 27.
- Results publication: PubMed 20008914Usui Y, Kobayashi T, Kakinuma H, Watanabe K, Kitajima T, Matsuno K. An anatomical basis for blocking of the deep cervical plexus and cervical sympathetic tract using an ultrasound-guided technique. Anesth Analg. 2010 Mar 1;110(3):964-8. doi: 10.1213/ANE.0b013e3181c91ea0. Epub 2009 Dec 15.
- Results publication: PubMed 21106978Choquet O, Dadure C, Capdevila X. Ultrasound-guided deep or intermediate cervical plexus block: the target should be the posterior cervical space. Anesth Analg. 2010 Dec;111(6):1563-4; author reply 1564-5. doi: 10.1213/ANE.0b013e3181f1d48f. No abstract available.
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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.
Isabelle LEBLANC, Doctor principal investigator
Institut Mutualiste Montsouris
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 Artery Stenosis, run by Institut Mutualiste Montsouris 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 1 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 21 May 2015. 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?
quality of anesthesia (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02450734, which also lists 3 linked publications.
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 21 May 2015.