Ultrasound-guided Intermediate Cervical Plexus Block

Internal Carotid Artery Stenosis Clinical Trial

Official title:

Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794974
• Other study ID #: A 2016-0027
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: August 2017

Study information

• Verified date: November 2018
• Source: Helios Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators test with the present study design, whether an ultrasound-guided blockade of the cervical plexus in combination with an additional application of local anesthetic to the superficial cervical ansa (facial nerve: cervical branch) leads to an improved quality of anesthesia.

Description:

The innervation of the neck area is complex and includes cranial nerve (innervation of the vessel wall (IX,X) and of the neck muscles (VII,XI)), as well as the cervical plexus and brachial plexus. This is a major cause of insufficient anesthesia quality during carotid endarterectomies.

The investigators test with the present prospective study design, whether an ultrasound-guided blockade of the cervical plexus in combination with an additional application of local anesthetic to the superficial cervical ansa (facial nerve: cervical branch) leads to an improved quality of anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• internal carotid stenosis: open surgical revascularization

• age over 18 years

• written informed consent

Exclusion Criteria:

• allergy (local anesthetics)

• pregnancy

• participation in other studies

• drug addiction

• non-cooperative patients

Related Conditions & MeSH terms

• Carotid Stenosis
• Internal Carotid Artery Stenosis

Intervention

Other:
• cervical plexus block
ultrasound-guided application of 20ml ropivacaine 0.75%
• facial nerve block
ultrasound-guided application of 5ml prilocaine 1%
• perivascular block
ultrasound-guided application of 5ml prilocaine 1%

Locations

Country	Name	City	State
Germany	Helios Medical Center Schwerin, Department of Anaesthesiology and Intensive Care	Schwerin	Mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
Helios Research Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Anesthetic Supplementation (Frequency)	number of participants who need supplementation of prilocaine 1% by the surgeon (%)	intraoperatively
Primary	Local Anesthetic Supplementation (Volume)	volume of prilocaine 1% supplemented by the surgeon (ml)	intraoperatively
Secondary	Hoarseness	number of participants who experienced side effects: hoarseness	intraoperatively
Secondary	Cough	number of participants who experienced side effects: cough	intraoperatively
Secondary	Dysphagia	number of participants who experienced side effects: dysphagia	intraoperatively