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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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%) |
|
| without perivascular block | Experimental | 1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. facial nerve block (cervical branch) (5ml prilocaine 1%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cervical plexus block | Other | ultrasound-guided application of 20ml ropivacaine 0.75% |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hoarseness | number of participants who experienced side effects: hoarseness | intraoperatively |
| Cough | number of participants who experienced side effects: cough |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Seidel, MD | Helios Medical Center Schwerin, Department of Anesthesiology and Intensive care, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helios Medical Center Schwerin, Department of Anaesthesiology and Intensive Care | Schwerin | Mecklenburg-Vorpommern | 19055 | Germany |
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The patients were recruited as part of the preoperative information discussion. All patients received an intermediate cervical plexus block and a facial nerve block (cervical branch, superficial cervical ansa). The decision on an additional perivascular infiltration was made by an experienced physician on the basis of sonoanatomic properties.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervical Plexus and Facial Nerve Block | 1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. block of the facial nerve (cervical branch) (5ml prilocaine 1%) cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75% facial nerve block: ultrasound-guided application of 5ml prilocaine 1% |
| FG001 | Cervical Plexus, Perivascular and Facial Nerve Block | 1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. block of the facial nerve (cervical branch) (5ml prilocaine 1%) 3. perivascular local anesthetic infiltration (5ml prilocaine 1%) cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75% facial nerve block: ultrasound-guided application of 5ml prilocaine 1% perivascular block: ultrasound-guided application of 5ml prilocaine 1% |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervical Plexus, Perivascular and Facial Nerve Block | 1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. block of the facial nerve (cervical branch) (5ml prilocaine 1%) 3. perivascular local anesthetic infiltration (5ml prilocaine 1%) cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75% facial nerve block: ultrasound-guided application of 5ml prilocaine 1% perivascular block: ultrasound-guided application of 5ml prilocaine 1% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Local Anesthetic Supplementation (Frequency) | number of participants who need supplementation of prilocaine 1% by the surgeon (%) | Posted | Number | participants | intraoperatively |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Without Perivascular Block | 1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. facial nerve block (cervical branch) (5ml prilocaine 1%) cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75% facial nerve block: ultrasound-guided application of 5ml prilocaine 1% |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Seidel | HELIOS Medical Center Schwerin, Germany | +49 385 5204251 | ronald.seidel@helios-kliniken.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2016 | Nov 20, 2017 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 22, 2016 | Nov 28, 2018 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D066008 | Cervical Plexus Block |
| ID | Term |
|---|---|
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| facial nerve block | Other | ultrasound-guided application of 5ml prilocaine 1% |
|
|
| perivascular block | Other | ultrasound-guided application of 5ml prilocaine 1% |
|
|
| intraoperatively |
| Dysphagia | number of participants who experienced side effects: dysphagia | intraoperatively |
| BG001 | Cervical Plexus and Facial Nerve Block | 1. ultrasound-guided intermediate cervical plexus block (20ml ropivacaine 0.75%) 2. block of the facial nerve (cervical branch) (5ml prilocaine 1%) cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75% facial nerve block: ultrasound-guided application of 5ml prilocaine 1% |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Primary | Local Anesthetic Supplementation (Volume) | volume of prilocaine 1% supplemented by the surgeon (ml) | Posted | Mean | Standard Deviation | ml | intraoperatively |
|
|
|
|
| Secondary | Hoarseness | number of participants who experienced side effects: hoarseness | Posted | Number | participants | intraoperatively |
|
|
|
|
| Secondary | Cough | number of participants who experienced side effects: cough | Posted | Number | participants | intraoperatively |
|
|
|
|
| Secondary | Dysphagia | number of participants who experienced side effects: dysphagia | Posted | Number | participants | intraoperatively |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | With Perivascular Block | 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%) cervical plexus block: ultrasound-guided application of 20ml ropivacaine 0.75% facial nerve block: ultrasound-guided application of 5ml prilocaine 1% perivascular block: ultrasound-guided application of 5ml prilocaine 1% | 0 | 14 | 0 | 14 | 0 | 14 |
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| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |