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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ropivacaine | Active Comparator | Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%. |
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| saline | Placebo Comparator | Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intermediate cervical plexus block ropivacaine | Drug | 20ml ultrasound guided intermediate cervical plexus block. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Required Supplementation of Local Anesthetic by Surgeon | during the intraoperative period | |
| Amount (ml) of Local Anesthetic Supplemented by Surgeon | during the intraoperative period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Seidel, Dr.med. | Helios Kliniken Schwerin, Klinik für Anästhesiologie und Intensivtherapie, Wismarsche Strasse 393-7, 19049 Schwerin, Germany | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ropivacaine | Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%. intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block. pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration. jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| pericarotidal infiltration (active comparator) ropivacaine | Drug | 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration. |
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| jugular infiltration prilocaine | Drug | 5ml prilocaine 1% jugular infiltration for wound drainage. |
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| pericarotidal infiltration (placebo comparator) saline | Drug | 5ml saline 0.9% (placebo comparator): pericarotidal infiltration. |
|
| FG001 | Saline | Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%. intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block. jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage. pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ropivacaine | Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%. intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block. pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration. jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage. |
| BG001 | Saline | Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%. intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block. jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage. pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Patients With Required Supplementation of Local Anesthetic by Surgeon | Posted | Number | participants | during the intraoperative period |
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| Primary | Amount (ml) of Local Anesthetic Supplemented by Surgeon | Posted | Mean | 95% Confidence Interval | ml | during the intraoperative period |
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during the intraoperative period
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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 | Ropivacaine | Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%. intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block. pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration. jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage. | 1 | 20 | 17 | 20 | ||
| EG001 | Saline | Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%. intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block. jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage. pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration. | 0 | 20 | 13 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| definitive stroke | Nervous system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| temporarily hoarseness | Nervous system disorders | Systematic Assessment |
| ||
| temporarily dysphagia | Nervous system disorders | Systematic Assessment |
| ||
| cough | Nervous system disorders | Systematic Assessment |
| ||
| Horner syndrome | Nervous system disorders | Systematic Assessment |
| ||
| temporarily paresis of the hypoglossal nerve | Nervous system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. med. Ronald Seidel | Helios Kliniken Schwerin | 0049 (0)385 5204251 | ronald.seidel@helios-kliniken.de |
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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