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

Carotid Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336958
• Other study ID #: A 2013-0075
• Status: Completed
• Phase: N/A
• First received: January 2, 2015
• Last updated: March 12, 2015
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Helios Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Stenosis

Intervention

Drug:
• intermediate cervical plexus block ropivacaine
20ml ultrasound guided intermediate cervical plexus block.
• pericarotidal infiltration (active comparator) ropivacaine
5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.
• jugular infiltration prilocaine
5ml prilocaine 1% jugular infiltration for wound drainage.
• pericarotidal infiltration (placebo comparator) saline
5ml saline 0.9% (placebo comparator): pericarotidal infiltration.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helios Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Required Supplementation of Local Anesthetic by Surgeon		during the intraoperative period	No
Primary	Amount (ml) of Local Anesthetic Supplemented by Surgeon		during the intraoperative period	No