NCT02794974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 9, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 16, 2018

Completed
Last Updated

December 19, 2018

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

May 31, 2016

Results QC Date

November 20, 2017

Last Update Submit

November 28, 2018

Conditions

Internal Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (2)

  • Local Anesthetic Supplementation (Frequency)

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

    intraoperatively

  • Local Anesthetic Supplementation (Volume)

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

    intraoperatively

Secondary Outcomes (3)

  • Hoarseness

    intraoperatively

  • Cough

    intraoperatively

  • Dysphagia

    intraoperatively

Study Arms (2)

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%)

Other: cervical plexus blockOther: facial nerve blockOther: perivascular block

without perivascular block

EXPERIMENTAL

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

Other: cervical plexus blockOther: facial nerve block

Interventions

cervical plexus blockOTHER

ultrasound-guided application of 20ml ropivacaine 0.75%

Also known as: cervical plexus anesthesia
with perivascular blockwithout perivascular block
facial nerve blockOTHER

ultrasound-guided application of 5ml prilocaine 1%

Also known as: facial nerve anesthesia
with perivascular blockwithout perivascular block
perivascular blockOTHER

ultrasound-guided application of 5ml prilocaine 1%

Also known as: perivascular infiltration
with perivascular block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • internal carotid stenosis: open surgical revascularization
  • age over 18 years
  • written informed consent

You may not qualify if:

  • allergy (local anesthetics)
  • pregnancy
  • participation in other studies
  • drug addiction
  • non-cooperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helios Medical Center Schwerin, Department of Anaesthesiology and Intensive Care

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Cervical Plexus Block

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Results Point of Contact

Title
Ronald Seidel
Organization
HELIOS Medical Center Schwerin, Germany
ronald.seidel@helios-kliniken.de
+49 385 5204251

Study Officials

  • Ronald Seidel, MD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 9, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

December 19, 2018

Results First Posted

August 16, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)