Intermediate Cervical Plexus Block for Carotid EndarterectomyPhase 4NCT01759940
Influence of the Concentration of the Local Anesthetic Ropivacaine on the Quality of a Ultrasound Guided Intermediate Cervical Block.
A Phase 4 study testing ropivacaine 0,375% and ropivacaine 0,75% in people with Intermediate Cervical Plexus Block for Carotid Endarterectomy, run by Salzburger Landeskliniken at 1 site in Austria.
Trial summary
Carotid endarterectomy is commonly performed under cervical plexus block. This is presumed to offer advantages over general anesthesia in terms of monitoring neurological function during cross-clamping of the carotid artery since, in conscious patients, speech, cerebration, and motor power provide early measures of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermediate Cervical Plexus Block for Carotid Endarterectomy
- What is being tested?
- ropivacaine 0,375% and ropivacaine 0,75%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2012to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- patients scheduled for carotid endarterectomy in regional anesthesia
Who cannot join
- refusal to participate in the trail
- age < 18a
- gestation/breastfeeding
- contraindication for regional anesthesia
Trial locations and contacts
1 site in 1 country.
Austria1 site
Klinik für Anästhesiologie, perioperative Medizin und allgemeine Intensivmedizin
Salzburg, State of Salzburg, 5020
About this study
Official title: Influence of the Concentration of the Local Anesthetic Ropivacaine on the Quality of a Ultrasound Guided Block of the Regio Collis Lateralis for Carotid Endarterectomy: a Prospective, Randomized and Controlled Trail
Carotid endarterectomy is commonly performed under cervical plexus block. This is presumed to offer advantages over general anesthesia in terms of monitoring neurological function during cross-clamping of the carotid artery since, in conscious patients, speech, cerebration, and motor power provide early measures of inadequate cerebral perfusion. Some studies also claim lower shunting requirements, lower cardiovascular morbidity, and shorter hospital stay.
Traditionally, the common methods of cervical plexus block are termed 'deep' or 'superficial'. The deep block, as described by Moore or Winnie and colleagues, consists of identifying the transverse processes of upper cervical vertebrae C2 - C4 and injecting local anesthetic directly into the deep (prevertebral) cervical space. This may be achieved either as separate injections or as a single injection. The superficial block incorporates a variety of procedures. The simplest is a s.c. infiltration of local anesthetic along the posterior border of sternocleidomastoid muscle by either the surgeon or the anesthetist.
Read more
An 'intermediate' block is one where the injecting needle pierces the investing fascia of the neck, deep to the s.c. layer, but superficial to the deep cervical (prevertebral) fascia. It is also possible to use a 'combined block', consisting of a deep injection and a superficial or intermediate injection.
Practitioners may prefer one block to another, but no consensus exists on the efficacy of one block when compared with another. However, it has been suggested that complications of the technique are related to the deep injection and not the superficial (or intermediate) injection. These complications include intrathecal or intravascular injection, respiratory problems related to phrenic nerve paralysis, or local anaesthetic toxicity.
In this study the Influence of the concentration of the local anesthetic ropivacaine on the quality of the intermediate cervical plexus block for carotid endarterectomy will be evaluated. For this purpose two different concentrations of ropivacaine will be compared (3,75% vs 7,5%). The primary endpoint of the study will be the quantity of the additional needed local anesthetic to achieve adequate operative analgesia. Furthermore we will record the frequency of the most common side effects as well as the patient satisfaction with a standardized questionnaire.
- Being tested
- ropivacaine 0,375%, ropivacaine 0,75%
- Keywords
- carotid, endarterectomy, cervical block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine 0,375%Drug
ropivacaine 0,75%Drug
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine 0,375% | Experimental | In the study group the intermediate cervical block will be performed by ultrasound guidance using 20ml ropivacaine 0,375%. Additionally 10ml prilocaine 1% will be used to infiltrate the perivascular tissue around the carotid artery. In the area of the expected incision the skin will also be infiltrated with 10ml prilocaine 1%. Receives: Drug: ropivacaine 0,375% |
| ropivacaine 0,75% | Active comparator | In the control group the intermediate cervical block will be performed by ultrasound guidance using 20ml ropivacaine 0,75%. Additionally 10ml prilocaine 1% will be used to infiltrate the perivascular tissue around the carotid artery. In the area of the expected incision the skin will also be infiltrated with 10ml prilocaine 1%. Receives: Drug: ropivacaine 0,75% |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of additional needed local anesthetics by the surgeon
The surgeon will titrate the local anesthetic lidocaine 2%to achieve adequate operative analgesia for the patient. During the surgical procedure the patient will not be sedated therefore distinct communication to the patient is always possible.
Measured: The primary endpoint will be evaluated continuously during the ongoing surgery by interrogating the patients pain scale every two to five minutes. In average the whole procedure will take 30 to 50 minutes.
Secondary outcomes (3)
plasma concentrations of ropivacaine
measured with mass spectrometry
Measured: until 8h postoperative
vital signs
continuous recording of vital signs during the surgery as well as in the postoperative ICU
Measured: whole day of surgery
effect on the diaphragm function
assessment of phrenic nerve paresis by ultrasound measurement of the diaphragm excursions, performed by the radiologist on call
Measured: until 6 h postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intermediate Cervical Plexus Block for Carotid EndarterectomyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salzburger Landeskliniken
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Kokoefer, Salzburger Landeskliniken
- Investigators
- Andreas Kokoefer, MD, Principal investigator, Salk Institute for Biological Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759940
- Sponsor's protocol ID
- cervicalblock
- Other IDs
- 2012-002769-37
- Status last verified
- Mar 2014
- First submitted
- 31 Dec 2012
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kokofer A, Nawratil J, Felder TK, Stundner O, Mader N, Gerner P. Ropivacaine 0.375% vs. 0.75% with prilocaine for intermediate cervical plexus block for carotid endarterectomy: A randomised trial. Eur J Anaesthesiol. 2015 Nov;32(11):781-9. doi: 10.1097/EJA.0000000000000243.
PubMed 25782662
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Concentration of the Local Anesthetic Ropivacaine on the Quality of a Ultrasound Guided Block of the Regio Collis Lateralis for Carotid Endarterectomy: a Prospective, Randomized and Controlled Trail
- ClinicalTrials.gov ID
- NCT01759940
- Acronym / sponsor ID
- cervicalblock
- Keywords
- carotid, endarterectomy, cervical block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Salzburger LandesklinikenUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Carotid endarterectomy is commonly performed under cervical plexus block. This is presumed to offer advantages over general anesthesia in terms of monitoring neurological function during cross-clamping of the carotid artery since, in conscious patients, speech, cerebration, and motor power provide early measures of inadequate cerebral perfusion. Some studies also claim lower shunting requirements, lower cardiovascular morbidity, and shorter hospital stay.
Traditionally, the common methods of cervical plexus block are termed 'deep' or 'superficial'. The deep block, as described by Moore or Winnie and colleagues, consists of identifying the transverse processes of upper cervical vertebrae C2 - C4 and injecting local anesthetic directly into the deep (prevertebral) cervical space. This may be achieved either as separate injections or as a single injection. The superficial block incorporates a variety of procedures. The simplest is a s.c. infiltration of local anesthetic along the posterior border of sternocleidomastoid muscle by either the surgeon or the anesthetist.
An 'intermediate' block is one where the injecting needle pierces the investing fascia of the neck, deep to the s.c. layer, but superficial to the deep cervical (prevertebral) fascia. It is also possible to use a 'combined block', consisting of a deep injection and a superficial or intermediate injection.
Practitioners may prefer one block to another, but no consensus exists on the efficacy of one block when compared with another. However, it has been suggested that complications of the technique are related to the deep injection and not the superficial (or intermediate) injection. These complications include intrathecal or intravascular injection, respiratory problems related to phrenic nerve paralysis, or local anaesthetic toxicity.
In this study the Influence of the concentration of the local anesthetic ropivacaine on the quality of the intermediate cervical plexus block for carotid endarterectomy will be evaluated. For this purpose two different concentrations of ropivacaine will be compared (3,75% vs 7,5%). The primary endpoint of the study will be the quantity of the additional needed local anesthetic to achieve adequate operative analgesia. Furthermore we will record the frequency of the most common side effects as well as the patient satisfaction with a standardized questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropivacaine 0,375% | Experimental | Drug: ropivacaine 0,375%In the study group the intermediate cervical block will be performed by ultrasound guidance using 20ml ropivacaine 0,375%. Additionally 10ml prilocaine 1% will be used to infiltrate the perivascular tissue around the carotid artery. In the area of the expected incision the skin will also be infiltrated with 10ml prilocaine 1%. |
| ropivacaine 0,75% | Active comparator | Drug: ropivacaine 0,75%In the control group the intermediate cervical block will be performed by ultrasound guidance using 20ml ropivacaine 0,75%. Additionally 10ml prilocaine 1% will be used to infiltrate the perivascular tissue around the carotid artery. In the area of the expected incision the skin will also be infiltrated with 10ml prilocaine 1%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled for carotid endarterectomy in regional anesthesia
Key exclusion criteria (4 listed)
- refusal to participate in the trail
- age < 18a
- gestation/breastfeeding
- contraindication for regional anesthesia
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 |
|---|---|---|
| ropivacaine 0,375% | Drug | ropivacaine 0,375% |
| ropivacaine 0,75% | Drug | ropivacaine 0,75% |
Primary outcome
amount of additional needed local anesthetics by the surgeon
Time frame: The primary endpoint will be evaluated continuously during the ongoing surgery by interrogating the patients pain scale every two to five minutes. In average the whole procedure will take 30 to 50 minutes.
The surgeon will titrate the local anesthetic lidocaine 2%to achieve adequate operative analgesia for the patient. During the surgical procedure the patient will not be sedated therefore distinct communication to the patient is always possible.
3 secondary outcomes
plasma concentrations of ropivacaine
Time frame: until 8h postoperative
vital signs
Time frame: whole day of surgery
effect on the diaphragm function
Time frame: until 6 h postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
- Derived from this study: PubMed 25782662Kokofer A, Nawratil J, Felder TK, Stundner O, Mader N, Gerner P. Ropivacaine 0.375% vs. 0.75% with prilocaine for intermediate cervical plexus block for carotid endarterectomy: A randomised trial. Eur J Anaesthesiol. 2015 Nov;32(11):781-9. doi: 10.1097/EJA.0000000000000243.
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.
Andreas Kokoefer, MD principal investigator
Salk Institute for Biological Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ropivacaine 0,375% and ropivacaine 0,75% in people with Intermediate Cervical Plexus Block for Carotid Endarterectomy, run by Salzburger Landeskliniken at 1 site in Austria.
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 1 inclusion and 4 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 18 Mar 2014. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
amount of additional needed local anesthetics by the surgeon (time frame: The primary endpoint will be evaluated continuously during the ongoing surgery by interrogating the patients pain scale every two to five minutes. In average the whole procedure will take 30 to 50 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01759940, which also lists 1 linked publication.
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 18 Mar 2014; AzTrials last refreshed its copy on 8 Nov 2026.