Ultrasound Guidance vs. Electrical Stimulation for Perineural Catheter Insertion: A Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The primary outcome measurement will be the time of placement for a perineural catheter using either ultrasound-guided method or electrical stimulation method.
研究概览
简要总结
This research study is to determine the relative times for perineural catheter placement with the use of ultrasound versus electrical stimulation. The perineural catheter is placed next to the nerves through which local anesthetic is placed to provide pain control following surgery. This study may determine if one method is associated with increased success rate and patient comfort.
详细描述
Primary Specific Aim: To determine if the relative times for perineural catheter placement with the use of ultrasound versus electrical stimulation.
Hypothesis
Compared with the use of electrical stimulation, the use of ultrasound guidance when inserting a perineural catheter is associated with a decreased time of placement.
Secondary Specific Aim: To determine if other possible benefits of perineural catheter placement associated with the use of ultrasound guidance versus electrical stimulation.
Hypothesis
Compared with the use of electrical stimulation, the use of ultrasound guidance when inserting a perineural catheter is associated with an increased surgical block success rate and catheter-placement success rate, as well as decreased patient discomfort and incidence of venous puncture.
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
- None
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
- •undergoing surgery with a planned perineural catheter for postoperative analgesia
- •catheter in the interscalene, infraclavicular, popliteal, or femoral anatomic location
- •age 18 years or older
排除标准
- •pregnancy
- •inability to communicate with the investigators and hospital staff
- •incarceration
研究组 & 干预措施
1. Ultrasound
Ultrasound is randomly chosen by use of a computer program. The time for catheter placement will begin with the ultrasound probe touches the patient. Patients will be asked their discomfort on a 0-10 scale (0=no discomfort and 10=worst discomfort imaginable) and will be called the next day by the research staff.
干预措施: perineural mepivicaine catheter placed via ultrasound or electrical stimulation (Procedure)
2. Electrical Stimulation
Nerve Stimulation (electrical stimulation) is randomly chosen using a computer program. Time of placement begins when the catheter-placement first touches the patient. After catheter placement patient is asked their discomfort on a 0-10 scale (0=no discomfort and 10=worst discomfort imaginable) and called the day after surgery by the research staff.
干预措施: perineural mepivicaine catheter placed via ultrasound or electrical stimulation (Procedure)
结局指标
主要结局
The primary outcome measurement will be the time of placement for a perineural catheter using either ultrasound-guided method or electrical stimulation method.
时间窗: 30 minutes
次要结局
- Pain and discomfort as assessed by a 0-10 scale (0=no pain/discomfort and 10=worst pain/discomfort imaginable) by the research coordinator.(After catheter placement and Postoperative day 1)