Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-21 @ 2:30 PM
Study NCT ID:
NCT02336958
Status:
COMPLETED
Last Update Posted:
2015-03-23
First Post:
2015-01-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration
Sponsor:
Helios Research Center
Organization:
Study Overview
Official Title:
Ultrasound Guided Intermediate Cervical Plexus Block -Randomized Evaluation Concerning the Significance of Additional Perivascular Local Anesthetic Infiltration
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: