Clinical Trials Directory

Trials / Completed

CompletedNCT02336958

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Helios Research Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DRUGintermediate cervical plexus block ropivacaine20ml ultrasound guided intermediate cervical plexus block.
DRUGpericarotidal infiltration (active comparator) ropivacaine5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.
DRUGjugular infiltration prilocaine5ml prilocaine 1% jugular infiltration for wound drainage.
DRUGpericarotidal infiltration (placebo comparator) saline5ml saline 0.9% (placebo comparator): pericarotidal infiltration.

Timeline

Start date
2013-09-01
Primary completion
2014-12-01
Completion
2014-12-01
First posted
2015-01-13
Last updated
2015-03-23
Results posted
2015-03-23

Source: ClinicalTrials.gov record NCT02336958. Inclusion in this directory is not an endorsement.