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Ultrasound-guided Intermediate Cervical Plexus Block

NCT ID: NCT02794974

Last Updated: 2018-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Internal Carotid Artery Stenosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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%)

Group Type EXPERIMENTAL

cervical plexus block

Intervention Type OTHER

ultrasound-guided application of 20ml ropivacaine 0.75%

facial nerve block

Intervention Type OTHER

ultrasound-guided application of 5ml prilocaine 1%

perivascular block

Intervention Type OTHER

ultrasound-guided application of 5ml prilocaine 1%

without perivascular block

1\. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. facial nerve block (cervical branch) (5ml prilocaine 1%)

Group Type EXPERIMENTAL

cervical plexus block

Intervention Type OTHER

ultrasound-guided application of 20ml ropivacaine 0.75%

facial nerve block

Intervention Type OTHER

ultrasound-guided application of 5ml prilocaine 1%

Interventions

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cervical plexus block

ultrasound-guided application of 20ml ropivacaine 0.75%

Intervention Type OTHER

facial nerve block

ultrasound-guided application of 5ml prilocaine 1%

Intervention Type OTHER

perivascular block

ultrasound-guided application of 5ml prilocaine 1%

Intervention Type OTHER

Other Intervention Names

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cervical plexus anesthesia facial nerve anesthesia perivascular infiltration

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helios Research Center

OTHER

Sponsor Role lead

Responsible Party

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Dr.med.Ronald Seidel

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronald Seidel, MD

Role: PRINCIPAL_INVESTIGATOR

Helios Medical Center Schwerin, Department of Anesthesiology and Intensive care,

Locations

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Helios Medical Center Schwerin, Department of Anaesthesiology and Intensive Care

Schwerin, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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A 2016-0027

Identifier Type: -

Identifier Source: org_study_id