Comparison of deep, intermediate and superficial regional anesthetic block for carotid surgery concerning nerval paresis, lung function and tissue distributio

Phase 1

Conditions: deep, intermediate or superficial cervical plexus block for carotid endarterectomy
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2017-001300-30-AT

Lead Sponsor: K für Anästhesieologie, Gemeinn. Sbg. Landeskliniken BetriebsgesmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- patient for planned, elective endarterectomies for symptomatic or asymptomatic stenosis of the carotid artery
- planned surgery under regional anesthesia
- consent to the study protocol after extensive information
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- age under 18 years, patients unable to consent
- pregnancy, lactation period
- contraindications for MRI study and/or contrast agent
- implants or incorporated material, e.g. cardiac pacemakers, prohibiting MRI study
- claustrophobia
- inability to remain inside of MRI due to physical restriction
- kidney impairement (GFR <30ml/min)
- liver failure (>Child A)
- contraindications to regional anesthesia and/or study medication
- severe lungdysfunction
- language or communications barrier prohibiting surgery under regional anesthesia

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to study the difference of extend or incidence of phrenic nerve paralysis measured by diaphragmatic motion after deep, intermediate or superficial cervical plexus blockade;Secondary Objective: to measure lung function and tissue distribution of the regional anesthetic injection after deep, intermediate or superficial cervical plexus blockade;Primary end point(s): difference in the change in diaphragmatic motion (in cm) before and after deep, intermediate or superficial cervical plexus blockade;Timepoint(s) of evaluation of this end point: before and after cervical plexusblockade

Secondary Outcome Measures