Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration
Information source: Helios Research Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carotid Stenosis
Intervention: intermediate cervical plexus block ropivacaine (Drug); pericarotidal infiltration (active comparator) ropivacaine (Drug); jugular infiltration prilocaine (Drug); pericarotidal infiltration (placebo comparator) saline (Drug)
Phase: N/A
Status: Completed
Sponsored by: Helios Research Center Official(s) and/or principal investigator(s): Ronald Seidel, Dr.med., Principal Investigator, Affiliation: Helios Kliniken Schwerin, Klinik für Anästhesiologie und Intensivtherapie, Wismarsche Strasse 393-7, 19049 Schwerin, Germany
Summary
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.
Clinical Details
Official title: Ultrasound Guided Intermediate Cervical Plexus Block -Randomized Evaluation Concerning the Significance of Additional Perivascular Local Anesthetic Infiltration
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Number of Patients With Required Supplementation of Local Anesthetic by SurgeonAmount (ml) of Local Anesthetic Supplemented by Surgeon
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: September 2013
Last updated: March 12, 2015
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