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Ultrasound-guided Intermediate Cervical Plexus Block

Primary Purpose

Internal Carotid Artery Stenosis

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

cervical plexus block

facial nerve block

perivascular block

About this trial

This is an interventional treatment trial for Internal Carotid Artery Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Helios Medical Center Schwerin, Department of Anaesthesiology and Intensive Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

with perivascular block

without perivascular block

Arm Description

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%)

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

Outcomes

Primary Outcome Measures

Local Anesthetic Supplementation (Frequency)

number of participants who need supplementation of prilocaine 1% by the surgeon (%)

Local Anesthetic Supplementation (Volume)

volume of prilocaine 1% supplemented by the surgeon (ml)

Secondary Outcome Measures

Hoarseness

number of participants who experienced side effects: hoarseness

Cough

number of participants who experienced side effects: cough

Dysphagia

number of participants who experienced side effects: dysphagia

Full Information

NCT ID

NCT02794974

First Posted

May 31, 2016

Last Updated

November 28, 2018

Sponsor

Helios Research Center

1. Study Identification

Unique Protocol Identification Number

NCT02794974

Brief Title

Ultrasound-guided Intermediate Cervical Plexus Block

Official Title

Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomies

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

May 2016 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helios Research Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Internal Carotid Artery Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

with perivascular block

Arm Type

Experimental

Arm Description

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%)

Arm Title

without perivascular block

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

cervical plexus block

Other Intervention Name(s)

cervical plexus anesthesia

Intervention Description

ultrasound-guided application of 20ml ropivacaine 0.75%

Intervention Type

Other

Intervention Name(s)

facial nerve block

Other Intervention Name(s)

facial nerve anesthesia

Intervention Description

ultrasound-guided application of 5ml prilocaine 1%

Intervention Type

Other

Intervention Name(s)

perivascular block

Other Intervention Name(s)

perivascular infiltration

Intervention Description

ultrasound-guided application of 5ml prilocaine 1%

Primary Outcome Measure Information:

Title

Local Anesthetic Supplementation (Frequency)

Description

number of participants who need supplementation of prilocaine 1% by the surgeon (%)

Time Frame

intraoperatively

Title

Local Anesthetic Supplementation (Volume)

Description

volume of prilocaine 1% supplemented by the surgeon (ml)

Time Frame

intraoperatively

Secondary Outcome Measure Information:

Title

Hoarseness

Description

number of participants who experienced side effects: hoarseness

Time Frame

intraoperatively

Title

Cough

Description

number of participants who experienced side effects: cough

Time Frame

intraoperatively

Title

Dysphagia

Description

number of participants who experienced side effects: dysphagia

Time Frame

intraoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Seidel, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Helios Medical Center Schwerin, Department of Anaesthesiology and Intensive Care

City

Schwerin

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

19055

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Ultrasound-guided Intermediate Cervical Plexus Block

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