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Clinical Trials/NCT02794974
NCT02794974CompletedNot Applicable

Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomies

Helios Research Center2 sites in 1 country29 target enrollmentStarted: May 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
29
Locations
2
Primary Endpoint
Local Anesthetic Supplementation (Volume)

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

with perivascular block

Experimental
  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%)

Intervention: cervical plexus block (Other)

with perivascular block

Experimental
  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%)

Intervention: facial nerve block (Other)

with perivascular block

Experimental
  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%)

Intervention: perivascular block (Other)

without perivascular block

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

Intervention: cervical plexus block (Other)

without perivascular block

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

Intervention: facial nerve block (Other)

Outcomes

Primary Outcomes

Local Anesthetic Supplementation (Volume)

Time Frame: intraoperatively

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

Local Anesthetic Supplementation (Frequency)

Time Frame: intraoperatively

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

Secondary Outcomes

  • Cough(intraoperatively)
  • Dysphagia(intraoperatively)
  • Hoarseness(intraoperatively)

Investigators

Sponsor
Helios Research Center
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr.med.Ronald Seidel

MD

Helios Research Center

Study Sites (2)

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