Internal Carotid Artery StenosisNCT02794974
Ultrasound-guided Intermediate Cervical Plexus Block
A study testing cervical plexus block, facial nerve block and perivascular block in people with Internal Carotid Artery Stenosis, run by Helios Research Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Internal Carotid Artery Stenosis
- What is being tested?
- cervical plexus block, facial nerve block and perivascular block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- internal carotid stenosis: open surgical revascularization
- age over 18 years
- written informed consent
Who cannot join
- allergy (local anesthetics)
- pregnancy
- participation in other studies
- drug addiction
- non-cooperative patients
Trial locations and contacts
1 site in 1 country.
Germany1 site
Helios Medical Center Schwerin, Department of Anaesthesiology and Intensive Care
Schwerin, Mecklenburg-Vorpommern, 19055
About this study
Official title: Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomies
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.
Read the 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.
- Conditions
- Internal Carotid Artery Stenosis
- Being tested
- cervical plexus block, facial nerve block, perivascular block
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical plexus blockOther
Also called cervical plexus anesthesia
ultrasound-guided application of 20ml ropivacaine 0.75%
facial nerve blockOther
Also called facial nerve anesthesia
ultrasound-guided application of 5ml prilocaine 1%
perivascular blockOther
Also called perivascular infiltration
ultrasound-guided application of 5ml prilocaine 1%
| Study group | Role | What they receive |
|---|---|---|
| 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%) Receives: Other: cervical plexus block; Other: facial nerve block; Other: 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%) Receives: Other: cervical plexus block; Other: facial nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Anesthetic Supplementation (Frequency)
number of participants who need supplementation of prilocaine 1% by the surgeon (%)
Measured: intraoperatively
Local Anesthetic Supplementation (Volume)
volume of prilocaine 1% supplemented by the surgeon (ml)
Measured: intraoperatively
Secondary outcomes (3)
Hoarseness
number of participants who experienced side effects: hoarseness
Measured: intraoperatively
Cough
number of participants who experienced side effects: cough
Measured: intraoperatively
Dysphagia
number of participants who experienced side effects: dysphagia
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Internal Carotid Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.med.Ronald Seidel, Helios Research Center
- Investigators
- Ronald Seidel, MD, Principal investigator, Helios Medical Center Schwerin, Department of Anesthesiology and Intensive care,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794974
- Sponsor's protocol ID
- A 2016-0027
- Status last verified
- Nov 2018
- First submitted
- 31 May 2016
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Endarterectomies
- ClinicalTrials.gov ID
- NCT02794974
- Acronym / sponsor ID
- A 2016-0027
- Conditions
- Internal Carotid Artery Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Helios Research CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Posted 16 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with perivascular block | Experimental | Other: cervical plexus block, Other: facial nerve block, Other: perivascular block1. 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%) |
| without perivascular block | Experimental | Other: cervical plexus block, Other: facial nerve block1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. facial nerve block (cervical branch) (5ml prilocaine 1%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- internal carotid stenosis: open surgical revascularization
- age over 18 years
- written informed consent
Key exclusion criteria (5 listed)
- allergy (local anesthetics)
- pregnancy
- participation in other studies
- drug addiction
- non-cooperative patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical plexus blockAlso: cervical plexus anesthesiaultrasound-guided application of 20ml ropivacaine 0.75% | Other | with perivascular block, without perivascular block |
| facial nerve blockAlso: facial nerve anesthesiaultrasound-guided application of 5ml prilocaine 1% | Other | with perivascular block, without perivascular block |
| perivascular blockAlso: perivascular infiltrationultrasound-guided application of 5ml prilocaine 1% | Other | with perivascular block |
Primary outcome
Local Anesthetic Supplementation (Frequency)
Time frame: intraoperatively
number of participants who need supplementation of prilocaine 1% by the surgeon (%)
Local Anesthetic Supplementation (Volume)
Time frame: intraoperatively
volume of prilocaine 1% supplemented by the surgeon (ml)
3 secondary outcomes
Hoarseness
Time frame: intraoperatively
Cough
Time frame: intraoperatively
Dysphagia
Time frame: intraoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Seidel, MD principal investigator
Helios Medical Center Schwerin, Department of Anesthesiology and Intensive care,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical plexus block, facial nerve block and perivascular block in people with Internal Carotid Artery Stenosis, run by Helios Research Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Anesthetic Supplementation (Frequency) (time frame: intraoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.