Sciatic Popliteal Nerve Block in Foot Surgery: Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Resting Visual Analogue Scale average in the first 24 hours
研究概览
简要总结
In practice ambulatory orthopedic surgery, one of the problems of most difficult solution is adequate control of postoperative analgesia. Pain is a frequent cause of consultation and unscheduled readmissions in this group of patients.
The use of continuous peripheral nerve blocks are an effective tool in postoperative analgesia.
In this connection, most of the studies of continuous infusions of local anesthetics by perineural catheters have been made with bupivacaine, levobupivacaine, and ropivacaine However, it has been found that lidocaine action lasts less, has lower cost and is less toxic than longer-acting agents.
The investigators aim is to compare the effectiveness of lidocaine versus bupivacaine continuous popliteal sciatic blockade ambulatory elastomeric pump.
详细描述
In the practice of orthopedic outpatient surgery, one of the most intractable problems is proper control of post-operative analgesia . Pain is a frequent cause of consultations and unscheduled readmissions in this group of patients.
The use of continuous peripheral nerve blocks are an effective tool in postoperative analgesia , allowing prolong the effect of the blockade by the time you want. Such techniques have been described by different groups for the management of postoperative pain with good results even successfully used in ambulatory practice .
However, sending patients home with a continuous infusion pump to local anesthetics causes some problems , such as the method of administration , cost and risk of poisoning by these drugs.
With regard to the method of administration , have been used electronic continuous infusion pumps even allow boluses of demand , with good results. However, its use implies a higher cost and are more difficult to use by patients.
An alternative of greater simplicity and lower cost is the use of disposable pumps ( elastomeric pumps ) without electronic components , which through a simple mechanism to allow a predetermined continuous infusion flow . It has been seen that the use of elastomeric pumps for continuous peripheral nerve blocks are associated with fewer technical problems and more satisfied patients electronic pumps .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists I or II
- •Body mass index between 20 and 34 kg/m2
- •Bilateral surgery of ankle or foot.
- •Peripheral nerve block and general anesthesia
排除标准
- •Chronic pain.
- •Illicit drug use
- •Pregnancy
- •Psychiatric disease
- •Chronic use of analgesia
- •Peripheral neuropathy
- •History of severe Gastroesophageal reflux disease
研究组 & 干预措施
Lidocaine
0.5% lidocaine infusion hour to 5 ml Baxter Infusor elastomeric pump 5 ml / hr.
干预措施: Lidocaine (Drug)
Bupivacaine
Infusion of 0.1% bupivacaine hour to 5 ml Baxter Infusor elastomeric pump 5 ml / hr.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Resting Visual Analogue Scale average in the first 24 hours
时间窗: 1 day
Visual analogue scale
次要结局
- Problems patient using the pump(7 days)
- Worse daily Visual Analogue Scale(7 days)
- Patient satisfaction(7 days)
- Number of patients using rescue analgesia and number of doses per patient(7 days)
- Resting and dynamic Visual Analogue Scale average in Post anesthesia care unit, 48, 72 hours and 7 days(7 days)