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OpenTrials
Completed

NCT Number: NCT02336958

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intermediate cervical plexus block ropivacaine

Drug

20ml ultrasound guided intermediate cervical plexus block.

pericarotidal infiltration (active comparator) ropivacaine

Drug

5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.

jugular infiltration prilocaine

Drug

5ml prilocaine 1% jugular infiltration for wound drainage.

pericarotidal infiltration (placebo comparator) saline

Drug

5ml saline 0.9% (placebo comparator): pericarotidal infiltration.

Primary outcomes

  1. Number of Patients With Required Supplementation of Local Anesthetic by Surgeon

    Time frame: during the intraoperative period

  2. Amount (ml) of Local Anesthetic Supplemented by Surgeon

    Time frame: during the intraoperative period

Sponsors and collaborators

Lead sponsor

Helios Research Center

Other

Registry information

Official study title

Ultrasound Guided Intermediate Cervical Plexus Block -Randomized Evaluation Concerning the Significance of Additional Perivascular Local Anesthetic Infiltration

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 13, 2015
Registry last updated
Mar 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.