Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration
- Conditions
- Carotid Stenosis
- Interventions
- Drug: intermediate cervical plexus block ropivacaineDrug: pericarotidal infiltration (active comparator) ropivacaineDrug: pericarotidal infiltration (placebo comparator) saline
- Registration Number
- NCT02336958
- Lead Sponsor
- Helios Research Center
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- carotid surgery (symptomatic and asymptomatic carotid stenosis)
- adult patients (18 years or older)
- ASA-risk-groups I-IV
- informed consent
- drug allergy: local anesthetics
- pregnancy, lactation period
- participation in other studies
- addiction to drugs or alcohol
- non-cooperative patients
- no approval to regional anesthesia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description saline jugular infiltration prilocaine Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%. ropivacaine jugular infiltration prilocaine Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%. ropivacaine pericarotidal infiltration (active comparator) ropivacaine Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%. saline intermediate cervical plexus block ropivacaine Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%. ropivacaine intermediate cervical plexus block ropivacaine Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%. saline pericarotidal infiltration (placebo comparator) saline Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.
- Primary Outcome Measures
Name Time Method Amount (ml) of Local Anesthetic Supplemented by Surgeon during the intraoperative period Number of Patients With Required Supplementation of Local Anesthetic by Surgeon during the intraoperative period
- Secondary Outcome Measures
Name Time Method