NCT04834440Unknown4 期
Ropivacaine Use in Femoral Nerve Block; What is the Minimal Effective Analgesic Concentration (MEAC 90)
Healthpoint Hospital2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- effective analgesic femoral nerve block
研究概览
简要总结
The aim of this study is to determine the minimal effective ropivacaine concentration required to provide adequate analgesic femoral nerve block in 90% of patients (MEAC90)
详细描述
- Before induction of GA, all patients will receive sciatic, obturator, lateral femoral cutaneous and femoral nerve blocks.
- The femoral nerve block will be performed using 15ml of ropivacaine which concentration relied on the response of the previous patient.
- Based on biased-coin design up-down sequential method: when a patient has a negative response, the next patient will receive a concentration 0.01% w/v higher. However if he has a positive response, the next patient will be randomized to receive either the same ropivacaine concentration or a concentration 0.01% w/v less.
- Patients with pain free recovery will be considered to have positive response.
- Patients' responses will be analyzed to calculate the MEAC90
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
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
- •Patients, who are scheduled for knee ligament reconstruction
排除标准
- •ASA physical class greater >III
- •BMI >40 has any contraindication for medications or techniques used in the study
结局指标
主要结局
effective analgesic femoral nerve block
时间窗: in recovery unit (one hour after surgery)
postoperative pain. it will be assessed using numerical rating scale (NRS). NRS, 0 = no pain; 10 = worst pain imaginable; if NRS ≥ 3, pain (ineffective block) is considered, other wise a successful block will be considered.
次要结局
未报告次要终点
研究者
Ahmad Muhammad Taha
Consultant of anesthesia
Healthpoint Hospital
研究点 (2)
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