跳至主要内容
临床试验/NCT00497354
NCT00497354已完成3 期

Does a Low Volume Ultrasound-Guided Technique Reduce Common Complications of Interscalene Brachial Plexus Block?

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2007年7月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
38
试验地点
2
主要终点
Diaphragmatic paresis

研究概览

简要总结

Peripheral nerve blocks provide many advantages for patients (excellent pain control and reduction in nausea) undergoing upper and lower limb surgery however several commonly occurring complications can produce annoying but sometimes serious adverse effects. The interscalene brachial plexus block (ISBPB) is one such technique, commonly performed for shoulder surgery, but also produces paralysis of the diaphragm, Horner's syndrome and sometimes vocal cord paralysis with standard volumes of local anesthetic. This threat of these side effects limits the use of ISBPB in many patients who would particularly benefit e.g. patients with lung disease. Recently the use of ultrasound guidance is allowing practitioners to place smaller volumes of local anesthetic with much greater accuracy. This can potentially avoid anesthetizing important adjacent nerves to the target structure. If ultrasound-guided techniques with smaller volumes of local anesthetic could be demonstrated to reduce the incidence of complications without reducing effectiveness this would be very beneficial for patients.This will be the first randomized, double blind study to evaluate if an ultrasound-guided ISBPB with low volumes of local anesthetic can reduce complications for patients whilst maintaining quality of anesthesia and pain relief in the intra-operative and postoperative period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective shoulder surgery.
  • Patients aged >=18 and <=70 years
  • ASA I-III

排除标准

  • Preexisting COPD
  • Unstable asthma
  • Psychiatric history
  • Allergy to ropivacaine.
  • Opioid tolerance (>30mg oral morphine or equivalent/day)

结局指标

主要结局

Diaphragmatic paresis

时间窗: 30 minutes post block insertion

次要结局

  • Analgesic efficacy(30,60,90,120 minutes post surgery)

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验