Is There a Difference Between Posterior Approach Ultrasound-guided Continuous Interscalene Block (Upper Trunk Block) and Stimulator Guided Continuous Cervical Paravertebral Block (C6 Root Block)?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Changes between the two groups assessed by sensory testing
研究概览
简要总结
This study will answer the question whether there is a difference in the effects and complication rates of ultrasound guided continuous interscalene block (CISB) and nerve stimulation-guided continuous cervical paravertebral block (CCPVB). The aim of this study is to evaluate the differences in efficacy and side effects - if any.
详细描述
This is a prospective randomized double-blinded study that will compare two commonly used approaches for the continuous blockade of the brachial plexus: the CCPVB, which focusses on the six cervical nerve root (C6 root), and CISB, which focuses on the upper trunk of the brachial plexus. Data of sensory testing, motor strength, shoulder pain, phrenic nerve function, recurrent laryngeal nerve (RNL) function, ipsilateral Horner's syndrome, block time and medication doses used for block placement, will be collected. All observations and measurements will be made by a member of the research team who is unaware of patient allocation to any particular group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The general inclusion will be those adult patients who:
- •are between the ages of 18 and 80 years
- •have an ASA Health Classification of I, II, or III
- •are scheduled for shoulder arthroplasty or rotator cuff repair surgery
- •Patients with a BMI of =to/< 40 Exclusion
- •The Exclusion criteria will include:
- •Patient refusal to participate in the study or sign informed consent
- •Patients with contraindications to any of the two blocks or allergy to any of the drugs used
- •Patients with shoulder surgery that developed into any other surgery other than total shoulder arthroplasty or rotator cuff repair
- •Patients with a BMI >40
排除标准
- 未提供
结局指标
主要结局
Changes between the two groups assessed by sensory testing
时间窗: Change from baseline up to 7 days (end of catheter placement)
Sensory abnormalities will be assessed by sensation of cold and dermatomes sensation.
次要结局
- Changes between the two groups assessed by recurrent laryngeal nerve (RLN) function(Change from baseline up to 7 days (end of catheter placement))
- Changes between the two groups assessed by shoulder pain(Change from baseline up to 7 days (end of catheter placement))
- Changes between the two groups assessed by motor strength(Change from baseline up to 7 days (end of catheter placement))
- Changes between the two groups assessed by Phrenic nerve function(Change from baseline up to 7 days (end of catheter placement))
- Changes between the two groups assessed by development of ipsilateral Horner's syndrome(Change from baseline up to 7 days (end of catheter placement))