The Minimum Effective Volume (MEV) of 0.5% Ropivacaine in Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB)
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The MEV90 of 0.5%Ropivacaine in Ultrasound-guided SASIS-FICBS
研究概览
简要总结
The Aim of This Study is to Determine the Minimum Effective Volume of Local Anesthetic (Ropivacaine 0.5%) Required to Produce an Effective Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block（SASIS-FICB） for Surgical Anesthesia in 90% of Patients Scheduled for Elective Surgery of One Lower Limbs.
详细描述
The study is based on biased coin design, and the volume of Local Anesthetic (Ropivacaine 0.5%) for the next patient is determined by the result of the last one. In the case of block failure, the volume will be increased by 2.5ml. Conversely, block success will result in either a reduction in volume by 2.5ml (probability 11%) or no change in volume (probability 89%). A blinded assistant will assess sensory and motor blockade in each nerve territory ( the femoral, obturator and lateral femoral cutaneous nerves) at 5-min intervals up to 30 min after completion of the block. Finally, MEV90 is calculated by isotonic regression.
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 undergoing hip/knee surgery
排除标准
- •age <18 years
- •body mass index >35
- •inability to consent to the study
- •allergy to local anesthetics
- •a history of liver or renal insufficiency, coagulopathy
- •clinical evidence of peripheral neuropathies, abnormalities of sensory or motor function of the FN, ON or LFCN.
研究组 & 干预措施
SASIS-FICB
All subjects will be enrolled in the experimental group and receive an Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB)
干预措施: Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) with 0.5% ropivacaine (Procedure)
SASIS-FICB
All subjects will be enrolled in the experimental group and receive an Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB)
干预措施: different volume of 0.5% ropivacaine (Drug)
结局指标
主要结局
The MEV90 of 0.5%Ropivacaine in Ultrasound-guided SASIS-FICBS
时间窗: up to 6 months
We prospectively recruited patients to receive different volumes of SASIS-FICB in accordance with the sequential trial rules of biased coins until 45 successful SASIS-FICB attempts were completed. MEV90 was calculated by isometric regression.
次要结局
未报告次要终点
研究者
Cui Xulei
Associate Professor
Peking Union Medical College Hospital