Ultrasound-guided Intermediate Cervical Plexus Block

Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomies

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.

Study Overview

• Status: Completed
• Conditions: Internal Carotid Artery Stenosis
• Intervention / Treatment: Other: cervical plexus block; Other: facial nerve block; Other: perivascular block

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Mecklenburg-Vorpommern
    • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
      • Helios Medical Center Schwerin, Department of Anaesthesiology and Intensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: with perivascular block; 1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. facial nerve block (cervical branch) (5ml prilocaine 1%) 3. perivascular block (5ml prilocaine 1%)	Other: cervical plexus block; ultrasound-guided application of 20ml ropivacaine 0.75%; Other Names: cervical plexus anesthesia; Other: facial nerve block; ultrasound-guided application of 5ml prilocaine 1%; Other Names: facial nerve anesthesia; Other: perivascular block; ultrasound-guided application of 5ml prilocaine 1%; Other Names: perivascular infiltration
Experimental: without perivascular block; 1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. facial nerve block (cervical branch) (5ml prilocaine 1%)	Other: cervical plexus block; ultrasound-guided application of 20ml ropivacaine 0.75%; Other Names: cervical plexus anesthesia; Other: facial nerve block; ultrasound-guided application of 5ml prilocaine 1%; Other Names: facial nerve anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Anesthetic Supplementation (Frequency)	number of participants who need supplementation of prilocaine 1% by the surgeon (%)	intraoperatively
Local Anesthetic Supplementation (Volume)	volume of prilocaine 1% supplemented by the surgeon (ml)	intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hoarseness	number of participants who experienced side effects: hoarseness	intraoperatively
Cough	number of participants who experienced side effects: cough	intraoperatively
Dysphagia	number of participants who experienced side effects: dysphagia	intraoperatively

Collaborators and Investigators

• Sponsor: Helios Research Center
• Investigators: Principal Investigator: Ronald Seidel, MD, Helios Medical Center Schwerin, Department of Anesthesiology and Intensive care,

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (Estimate): June 9, 2016

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: A 2016-0027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No