Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration

Helios Research Center

Status: Completed

Conditions: Carotid Stenosis

Treatments: Drug: pericarotidal infiltration (placebo comparator) saline; Drug: jugular infiltration prilocaine; Drug: pericarotidal infiltration (active comparator) ropivacaine; Drug: intermediate cervical plexus block ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02336958

A 2013-0075

Details and patient eligibility

About

For ultrasound guided intermediate cervical plexus block this randomized comparison is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.

Full description

The innervation of the neck is complex and involves the cervical and the brachial plexus as well as cranial nerves. So is the wall of the carotid arteries innervated by vagal and glossopharyngeal nerve as well as the sympathetic trunk. When carotid surgery was performed under regional anesthesia, so additional infiltration of local anesthetic by the surgeon was common, particularly during preparation of the carotid arteries.

Introduction of ultrasound guidance made it possible to guide the needle directly to the vascular wall. But this procedure is considered very demanding, because of guiding the needle in an anatomical region with artifacts (because of calcification), sudden movements (e.g. because of swallowing) and compromised coagulation (antithrombotic medication). On the other side there are no clinical data proving the benefit of an additional perivascular infiltration with local anesthetic. Therefore, this investigation is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• carotid surgery (symptomatic and asymptomatic carotid stenosis)
• adult patients (18 years or older)
• ASA-risk-groups I-IV
• informed consent

Exclusion criteria

• drug allergy: local anesthetics
• pregnancy, lactation period
• participation in other studies
• addiction to drugs or alcohol
• non-cooperative patients
• no approval to regional anesthesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

ropivacaine

Active Comparator group

Description:

Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.

Treatment:

Drug: intermediate cervical plexus block ropivacaine

Drug: jugular infiltration prilocaine

Drug: pericarotidal infiltration (active comparator) ropivacaine

saline

Placebo Comparator group

Description:

Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.

Treatment:

Drug: pericarotidal infiltration (placebo comparator) saline

Drug: intermediate cervical plexus block ropivacaine

Drug: jugular infiltration prilocaine