NCT02450734

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

2.1 years

First QC Date

May 19, 2015

Last Update Submit

May 20, 2015

Conditions

Keywords

ultrasound-guided intermediate cervical plexus block

Outcome Measures

Primary Outcomes (1)

  • quality of anesthesia

    assessed by the patient (quality scale) and absence of the need to general anesthesia

    immediate

Secondary Outcomes (1)

  • Hemodynamic stability

    immediate during surgery

Study Arms (1)

Carotid endarterectomy

Realisation of an ultrasound-guided intermediate cervical plexus block for anesthesia of carotid endarterectomy

Procedure: Ultrasound-guided intermediate cervical plexus block

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing carotid endarterectomy

You may qualify if:

  • Patients undergoing carotid endarterectomy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia Institut Mutualiste Montsouris

Paris, Paris, 75014, France

Location

Related Publications (3)

  • 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.

  • Usui 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.

  • Choquet 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.

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Isabelle LEBLANC, Doctor

    Institut Mutualiste Montsouris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 21, 2015

Study Start

April 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations