NCT01640613

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

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, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 6, 2014

Status Verified

March 1, 2014

Enrollment Period

1.5 years

First QC Date

July 6, 2012

Last Update Submit

March 5, 2014

Conditions

Carotid AtherosclerosisRegional Anesthesia Morbidity

Keywords

carotid endarterectomyregional anaesthesiaultrasound guided block

Outcome Measures

Primary Outcomes (1)

  • conversion to general anaesthesia

    surgery time

Secondary Outcomes (5)

  • amount of additional local anaesthetic

    surgery time

  • additional injection of remifentanil

    surgery time

  • complications

    anaesthesia time

  • patient and surgeon satisfactions

    after surgery

  • additional injection of remifentanil

    surgery time

Eligibility Criteria

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

patients undergoing carotid endarterectomy under regional anaesthesia

You may qualify if:

  • adult
  • carotid endarterectomy performed under regional anaesthesia

You may not qualify if:

  • age \< 18 years
  • contralateral phrenic palsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Anaesthesiology and Intensive Care, Edouard Heriot Hospital, HCL

Lyon, 69003, France

Location

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bernard Allaouchiche, MD PhD

    Edouard Heriot Hospital, HCL

    STUDY CHAIR

  • Emmanuel Boselli, MD PhD

    Edouard Heriot Hospital, HCL

    STUDY DIRECTOR

  • Anne-Laure Calderon, MD

    Edouard Heriot Hospital, HCL

    PRINCIPAL INVESTIGATOR

  • Cyrille Truc, MD

    Edouard Heriot Hospital, HCL

    PRINCIPAL INVESTIGATOR

  • Julien Davidson, MD

    Edouard Heriot Hospital, HCL

    PRINCIPAL INVESTIGATOR

  • Najia Rahali, MD

    Edouard Heriot Hospital, HCL

    PRINCIPAL INVESTIGATOR

  • Farida Benatir, MD

    Edouard Heriot Hospital, HCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md, PhD

Study Record Dates

First Submitted

July 6, 2012

First Posted

July 16, 2012

Study Start

April 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

March 6, 2014

Record last verified: 2014-03

Locations

FR(1)