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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 Surgeon

Amount (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

Page last updated: August 23, 2015

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