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Completed

NCT Number: NCT02794974

Ultrasound-guided Intermediate Cervical Plexus Block

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.

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Key information

Conditions

Internal Carotid Artery Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helios Medical Center Schwerin, Department of Anaesthesiology and Intensive Care

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cervical plexus block

Other

ultrasound-guided application of 20ml ropivacaine 0.75%

Other names: cervical plexus anesthesia

facial nerve block

Other

ultrasound-guided application of 5ml prilocaine 1%

Other names: facial nerve anesthesia

perivascular block

Other

ultrasound-guided application of 5ml prilocaine 1%

Other names: perivascular infiltration

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Helios Research Center

Other

Registry information

Official study title

Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomies

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 9, 2016
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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