Ultrasound-guided Intermediate Cervical Plexus Block

Not Applicable

Completed

• Conditions: Internal Carotid Artery Stenosis
• Interventions: Other: cervical plexus block; Other: facial nerve block; Other: perivascular block

• Registration Number: NCT02794974
• Lead Sponsor: Helios Research Center

Brief 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.

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 Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-31
• Study First Submitted QC: 2016-06-08
• Study First Posted: 2016-06-09
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Results First Submitted: 2017-11-20
• Results First Submitted QC: 2017-11-20
• Results First Posted: 2018-08-16
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with perivascular block	facial nerve 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%)
without perivascular block	cervical plexus block	1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. facial nerve block (cervical branch) (5ml prilocaine 1%)
with perivascular block	cervical plexus 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%)
with perivascular block	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%)
without perivascular block	facial nerve block	1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. facial nerve block (cervical branch) (5ml prilocaine 1%)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cough	intraoperatively	number of participants who experienced side effects: cough
Dysphagia	intraoperatively	number of participants who experienced side effects: dysphagia
Hoarseness	intraoperatively	number of participants who experienced side effects: hoarseness

Trial Locations

Locations (1)

Helios Medical Center Schwerin, Department of Anaesthesiology and Intensive Care; 🇩🇪 Schwerin, Mecklenburg-Vorpommern, Germany