A Comparison Between Neurostimulation and Loss of Resistance for Cervical Paravertebral Blocks
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Success
研究概览
简要总结
Cervical paravertebral blocks (CPVBs) target the brachial plexus from a puncture site situated in the posterior aspect of the neck and represent an alternative to interscalene blocks (ISBs) for shoulder and proximal humeral surgery. Randomized controlled trials comparing CPVB and ISB have found no significant differences in success rate, onset and offset times. Because of the reliability of their cutaneous landmarks, CPVBs have become part of the investigators' standard practice. With this approach, the brachial approach can be identified either with loss of resistance to air (LOR) or nerve stimulation (NS). While some authors have used only LOR and reported good success rates, others have hypothesized that NS may increase the reliability of the block. In the proposed study, for the first time, the 2 methods will be formally compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Single (Outcomes Assessor)
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
- 否
入选标准
- •age between 18 and 70 years
- •American Society of Anesthesiologists classification 1-3
- •body mass index between 20 and 28
排除标准
- •adults who are unable to give their own consent
- •pre-existing obstructive or restrictive lung disease (assessed by history and physical examination)
- •pre-existing neuropathy (assessed by history and physical examination)
- •coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets≤ 100, International Normalized Ratio≥ 1.4 or prothrombin time ≥ 50)
- •renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine≥ 100)
- •hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases≥ 100)
- •allergy to local anesthetic agents (LA)
- •pregnancy
- •prior cervical spine surgery
研究组 & 干预措施
1
CPVB with NS
干预措施: Nerve stimulation (Other)
2
CPVB with LOR
干预措施: Loss of resistance to air (Other)
结局指标
主要结局
Success
时间窗: 8 months
次要结局
- performance time, onset time, side effects(8 months)