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临床试验/NCT01759940
NCT01759940已完成4 期

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

Salzburger Landeskliniken1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
amount of additional needed local anesthetics by the surgeon

研究概览

简要总结

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.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients scheduled for carotid endarterectomy in regional anesthesia

排除标准

  • refusal to participate in the trail
  • age < 18a
  • gestation/breastfeeding
  • contraindication for regional anesthesia
  • inclusion in other trails

研究组 & 干预措施

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%.

干预措施: ropivacaine 0,375% (Drug)

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%.

干预措施: ropivacaine 0,75% (Drug)

结局指标

主要结局

amount of additional needed local anesthetics by the surgeon

时间窗: 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.

次要结局

  • plasma concentrations of ropivacaine(until 8h postoperative)
  • vital signs(whole day of surgery)
  • effect on the diaphragm function(until 6 h postoperative)

研究者

发起方
Salzburger Landeskliniken
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Kokoefer

MD

Salzburger Landeskliniken

研究点 (1)

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