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

Comparison of deep, intermediate and superficial cervical plexus block for carotid endarterectomies concerning paresis of the phrenic nerve, lung function and tissue distribution: a prospective, randomised-controlled, observerblinded study - Cervical plexus anesthesia study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001300-30-AT

Enrollment

Registered

2017-08-17

Start date

2017-10-03

Completion date

Unknown

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

deep, intermediate or superficial cervical plexus block for carotid endarterectomy

Interventions

Trade Name: Dotarem Product Name: Dotarem Pharmaceutical Form: Injection INN or Proposed INN: gadoterate meglumine CAS Number: 72573-82-1 Concentration unit: mg/ml milligram(s)/millilitre Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 Child A) - contraindications to regional anesthesia and/or study medication - severe lungdysfunction - language or communications barrier prohibiting surgery under regional anesthesia

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): - lung function tests (FEV1, FVC) before and after blockade - tissue distribution of local anesthetic solutaion and anatomical distance to nerval structures in the MRI - incidence of epidureal spread - mean Sp02 and paO2 measurements before and after blockade - supplementary oxygen before, during and after surgery - incidence of clinically relevant tachycardia, hypo/hypertension - incidence of conversion to general anesthesia - incidence of side effects of regional anesthesia (Horner's, Dysphagia, hoarseness, palsy of the facial or recurrent nerve) - amount of supplimental analgesia by fentanyl - amount of supplimental lokalanesthetic by surgeon - postoperative pain scores - surgery duration and clamping duration of the carotid artery - cerebral oxygenation - incidence and extent of temporary neurological symptoms - incidence of carotid shunting by surgeon - incidence of cardiovascular complications (cerebral ischemia, ACS) - patient satisfaction;Timepoint(s) of evaluation of this end point: as listed above, before and after block, or before, during and after surgery until discharge from monitoring ward	—

Measure

Time frame

Secondary end point(s): - lung function tests (FEV1, FVC) before and after blockade - tissue distribution of local anesthetic solutaion and anatomical distance to nerval structures in the MRI - incidence of epidureal spread - mean Sp02 and paO2 measurements before and after blockade - supplementary oxygen before, during and after surgery - incidence of clinically relevant tachycardia, hypo/hypertension - incidence of conversion to general anesthesia - incidence of side effects of regional anesthesia (Horner's, Dysphagia, hoarseness, palsy of the facial or recurrent nerve) - amount of supplimental analgesia by fentanyl - amount of supplimental lokalanesthetic by surgeon - postoperative pain scores - surgery duration and clamping duration of the carotid artery - cerebral oxygenation - incidence and extent of temporary neurological symptoms - incidence of carotid shunting by surgeon - incidence of cardiovascular complications (cerebral ischemia, ACS) - patient satisfaction;Timepoint(s) of evaluation of this end point: as listed above, before and after block, or before, during and after surgery until discharge from monitoring ward

—

Countries

Austria

Contacts

Public ContactDepartment office

UK für Anästhesieologie, Gemeinn. Sbg. Landeskliniken BetriebsgesmbH

00435725524004

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: May 22, 2026