Carotid StenosisNCT02336958
Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration
A study testing intermediate cervical plexus block ropivacaine, pericarotidal infiltration (active comparator) ropivacaine and jugular infiltration prilocaine in people with Carotid Stenosis, run by Helios Research Center.
Trial summary
For ultrasound guided intermediate cervical plexus block this randomized comparison is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- intermediate cervical plexus block ropivacaine, pericarotidal infiltration (active comparator) ropivacaine and jugular infiltration prilocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Dec 2014
- 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
- carotid surgery (symptomatic and asymptomatic carotid stenosis)
- adult patients (18 years or older)
- ASA-risk-groups I-IV
- informed consent
Who cannot join
- drug allergy: local anesthetics
- pregnancy, lactation period
- participation in other studies
- addiction to drugs or alcohol
- non-cooperative patients
- no approval to regional anesthesia
About this study
Official title: Ultrasound Guided Intermediate Cervical Plexus Block -Randomized Evaluation Concerning the Significance of Additional Perivascular Local Anesthetic Infiltration
For ultrasound guided intermediate cervical plexus block this randomized comparison is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.
Read the detailed description
The innervation of the neck is complex and involves the cervical and the brachial plexus as well as cranial nerves. So is the wall of the carotid arteries innervated by vagal and glossopharyngeal nerve as well as the sympathetic trunk. When carotid surgery was performed under regional anesthesia, so additional infiltration of local anesthetic by the surgeon was common, particularly during preparation of the carotid arteries.
Introduction of ultrasound guidance made it possible to guide the needle directly to the vascular wall. But this procedure is considered very demanding, because of guiding the needle in an anatomical region with artifacts (because of calcification), sudden movements (e.g. because of swallowing) and compromised coagulation (antithrombotic medication). On the other side there are no clinical data proving the benefit of an additional perivascular infiltration with local anesthetic. Therefore, this investigation is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.
- Conditions
- Carotid Stenosis
- Being tested
- intermediate cervical plexus block ropivacaine, pericarotidal infiltration (active comparator) ropivacaine, jugular infiltration prilocaine, pericarotidal infiltration (placebo comparator) saline
- Keywords
- cervical plexus, regional anesthesia, ultrasound, carotid surgery
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermediate cervical plexus block ropivacaineDrug
20ml ultrasound guided intermediate cervical plexus block.
pericarotidal infiltration (active comparator) ropivacaineDrug
5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.
jugular infiltration prilocaineDrug
5ml prilocaine 1% jugular infiltration for wound drainage.
pericarotidal infiltration (placebo comparator) salineDrug
5ml saline 0.9% (placebo comparator): pericarotidal infiltration.
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine | Active comparator | Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%. Receives: Drug: intermediate cervical plexus block ropivacaine; Drug: pericarotidal infiltration (active comparator) ropivacaine; Drug: jugular infiltration prilocaine |
| saline | Placebo comparator | Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%. Receives: Drug: intermediate cervical plexus block ropivacaine; Drug: jugular infiltration prilocaine; Drug: pericarotidal infiltration (placebo comparator) saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Required Supplementation of Local Anesthetic by Surgeon
Measured: during the intraoperative period
Amount (ml) of Local Anesthetic Supplemented by Surgeon
Measured: during the intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionDec 2014
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 Carotid 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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, Dr.med., Principal investigator, Helios Kliniken Schwerin, Klinik für Anästhesiologie und Intensivtherapie, Wismarsche Strasse 393-7, 19049 Schwerin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336958
- Sponsor's protocol ID
- A 2013-0075
- Status last verified
- Mar 2015
- First submitted
- 2 Jan 2015
- Last updated
- 23 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Intermediate Cervical Plexus Block -Randomized Evaluation Concerning the Significance of Additional Perivascular Local Anesthetic Infiltration
- ClinicalTrials.gov ID
- NCT02336958
- Acronym / sponsor ID
- A 2013-0075
- Conditions
- Carotid Stenosis
- Keywords
- cervical plexus, regional anesthesia, ultrasound, carotid surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Helios Research CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Posted 23 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For ultrasound guided intermediate cervical plexus block this randomized comparison is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.
Detailed description
The innervation of the neck is complex and involves the cervical and the brachial plexus as well as cranial nerves. So is the wall of the carotid arteries innervated by vagal and glossopharyngeal nerve as well as the sympathetic trunk. When carotid surgery was performed under regional anesthesia, so additional infiltration of local anesthetic by the surgeon was common, particularly during preparation of the carotid arteries.
Introduction of ultrasound guidance made it possible to guide the needle directly to the vascular wall. But this procedure is considered very demanding, because of guiding the needle in an anatomical region with artifacts (because of calcification), sudden movements (e.g. because of swallowing) and compromised coagulation (antithrombotic medication). On the other side there are no clinical data proving the benefit of an additional perivascular infiltration with local anesthetic. Therefore, this investigation is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropivacaine | Active comparator | Drug: intermediate cervical plexus block ropivacaine, Drug: pericarotidal infiltration (active comparator) ropivacaine, Drug: jugular infiltration prilocaineUltrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%. |
| saline | Placebo comparator | Drug: intermediate cervical plexus block ropivacaine, Drug: jugular infiltration prilocaine, Drug: pericarotidal infiltration (placebo comparator) salineUltrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- carotid surgery (symptomatic and asymptomatic carotid stenosis)
- adult patients (18 years or older)
- ASA-risk-groups I-IV
- informed consent
Key exclusion criteria (6 listed)
- drug allergy: local anesthetics
- pregnancy, lactation period
- participation in other studies
- addiction to drugs or alcohol
- 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 |
|---|---|---|
| intermediate cervical plexus block ropivacaine20ml ultrasound guided intermediate cervical plexus block. | Drug | ropivacaine, saline |
| pericarotidal infiltration (active comparator) ropivacaine5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration. | Drug | ropivacaine |
| jugular infiltration prilocaine5ml prilocaine 1% jugular infiltration for wound drainage. | Drug | ropivacaine, saline |
| pericarotidal infiltration (placebo comparator) saline5ml saline 0.9% (placebo comparator): pericarotidal infiltration. | Drug | saline |
Primary outcome
Number of Patients With Required Supplementation of Local Anesthetic by Surgeon
Time frame: during the intraoperative period
Amount (ml) of Local Anesthetic Supplemented by Surgeon
Time frame: during the intraoperative period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, Dr.med. principal investigator
Helios Kliniken Schwerin, Klinik für Anästhesiologie und Intensivtherapie, Wismarsche Strasse 393-7, 19049 Schwerin, Germany
Questions about this trial
What is this clinical trial studying?
A study testing intermediate cervical plexus block ropivacaine, pericarotidal infiltration (active comparator) ropivacaine and jugular infiltration prilocaine in people with Carotid Stenosis, run by Helios Research Center.
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 4 inclusion and 6 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 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 23 Mar 2015). 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?
Number of Patients With Required Supplementation of Local Anesthetic by Surgeon (time frame: during the intraoperative period). 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 23 Mar 2015.