Ultrasound Guided Intermediate Cervical Plexus Block -Randomized Evaluation Concerning the Significance of Additional Perivascular Local Anesthetic Infiltration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Amount (ml) of Local Anesthetic Supplemented by Surgeon
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •carotid surgery (symptomatic and asymptomatic carotid stenosis)
- •adult patients (18 years or older)
- •ASA-risk-groups I-IV
- •informed consent
排除标准
- •drug allergy: local anesthetics
- •pregnancy, lactation period
- •participation in other studies
- •addiction to drugs or alcohol
- •non-cooperative patients
- •no approval to regional anesthesia
研究组 & 干预措施
ropivacaine
Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.
干预措施: intermediate cervical plexus block ropivacaine (Drug)
ropivacaine
Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.
干预措施: pericarotidal infiltration (active comparator) ropivacaine (Drug)
ropivacaine
Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.
干预措施: jugular infiltration prilocaine (Drug)
saline
Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.
干预措施: intermediate cervical plexus block ropivacaine (Drug)
saline
Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.
干预措施: jugular infiltration prilocaine (Drug)
saline
Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.
干预措施: pericarotidal infiltration (placebo comparator) saline (Drug)
结局指标
主要结局
Amount (ml) of Local Anesthetic Supplemented by Surgeon
时间窗: during the intraoperative period
Number of Patients With Required Supplementation of Local Anesthetic by Surgeon
时间窗: during the intraoperative period
次要结局
未报告次要终点
研究者
Dr.med.Ronald Seidel
MD
Helios Research Center
