Successful Popliteal Block Using Lidocaine; What is the Minimum Effective Anesthesia Concentration (MEAC90)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 主要终点
- successful popliteal block (positive response)
研究概览
简要总结
using a biased-coin design up-down sequential method, different concentration of lidocaine will be used for popliteal block After 45 successful block (positive response), the data will be used to calculate the minimum lidocaine concentration that can result in successful popliteal block in 90% of patients
详细描述
The response of a patient determined the lidocaine concentration given to the next patient (a biased-coin design up-down sequential method). If a patient had a negative response, the lidocaine concentration was increased by 0.1% w/v in the next patient. If a patient had a positive response, the next patient was randomized to receive the same lidocaine concentration (with probability of 0.89), or to receive a concentration 0.1% w/v less (with probability of 0.11).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
the patients and the assessment staff will not be aware with the given lidocaine concentration
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
- •orthopedic foot or ankle surgery
- •day case surgery
排除标准
- •ASA class greater >III,
- •obese (BMI >30),
- •patients with low body weight, who required lidocaine dose is of more than 4.5mg.kg-1
- •peripheral neuropathy,
- •motor weakness,
- •infection at the injection site
- •any contraindications for medications in the study.
研究组 & 干预措施
lidocaine concentraion
the popliteal block will be performed (once) in all patients using 20 ml of lidoacine. The response of a patient determined the lidocaine concentration given to the next patient (a biased-coin design up-down sequential method). If a patient had a negative response (failed block), the lidocaine concentration was increased by 0.1% w/v in the next patient. If a patient had a positive response (successful block), the next patient was randomized to receive the same lidocaine concentration (with probability of 0.89), or to receive a concentration 0.1% w/v less (with probability of 0.11).
干预措施: Lidocaine (Drug)
结局指标
主要结局
successful popliteal block (positive response)
时间窗: 30 min to 3 hour after the block
Sensory block will be assessed using pinprick sensation. Complete sensory block = unable to recognize pinprick sensation. Intra-operative pain will be assessed using Visual Analogue Scale (VAS) 0 = No pain, 10 = Worst imaginable pain. Successful block = complete sensory block + pain free surgery (VAS = 0).
次要结局
- motor block(30 min after the block)
- motor recovery(3 hours till full recovery)
- analgesic duration(few hours after block)
研究者
Ahmad Muhammad Taha
Consultant of anesthesia
Healthpoint Hospital