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Ultrasound-guided Intermediate Cervical Plexus Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794974
Recruitment Status : Completed
First Posted : June 9, 2016
Results First Posted : August 16, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Dr.med.Ronald Seidel, 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.

Condition or disease Intervention/treatment Phase
Internal Carotid Artery Stenosis Other: cervical plexus block Other: facial nerve block Other: perivascular block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomies
Study Start Date : May 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: cervical plexus anesthesia

Other: facial nerve block
ultrasound-guided application of 5ml prilocaine 1%
Other Name: facial nerve anesthesia

Other: perivascular block
ultrasound-guided application of 5ml prilocaine 1%
Other Name: 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 Name: cervical plexus anesthesia

Other: facial nerve block
ultrasound-guided application of 5ml prilocaine 1%
Other Name: facial nerve anesthesia




Primary Outcome Measures :
  1. Local Anesthetic Supplementation (Frequency) [ Time Frame: intraoperatively ]
    number of participants who need supplementation of prilocaine 1% by the surgeon (%)

  2. Local Anesthetic Supplementation (Volume) [ Time Frame: intraoperatively ]
    volume of prilocaine 1% supplemented by the surgeon (ml)


Secondary Outcome Measures :
  1. Hoarseness [ Time Frame: intraoperatively ]
    number of participants who experienced side effects: hoarseness

  2. Cough [ Time Frame: intraoperatively ]
    number of participants who experienced side effects: cough

  3. Dysphagia [ Time Frame: intraoperatively ]
    number of participants who experienced side effects: dysphagia



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794974


Locations
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Germany
Helios Medical Center Schwerin, Department of Anaesthesiology and Intensive Care
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Sponsors and Collaborators
Helios Research Center
Investigators
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Principal Investigator: Ronald Seidel, MD Helios Medical Center Schwerin, Department of Anesthesiology and Intensive care,
  Study Documents (Full-Text)

Documents provided by Dr.med.Ronald Seidel, Helios Research Center:
Statistical Analysis Plan  [PDF] January 22, 2016
Study Protocol  [PDF] January 22, 2016

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Responsible Party: Dr.med.Ronald Seidel, MD, Helios Research Center
ClinicalTrials.gov Identifier: NCT02794974    
Other Study ID Numbers: A 2016-0027
First Posted: June 9, 2016    Key Record Dates
Results First Posted: August 16, 2018
Last Update Posted: December 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs