Minimum Effective Concentration (MEC90) for Supra-inguinal Fascia Iliaca Block Performed Under Ultrasound Guidance in Arthroscopic Knee Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Block Success
研究概览
简要总结
In this study, the minimum effective concentration required for supra-inguinal fascia iliaca block applied in patients undergoing arthroscopic knee surgery is aimed. The same volume will be used in all of the block applications in the study, and the local anesthetic concentration used will be determined by increasing or decreasing according to the success of the previous block. The primary goal of the study is block success.
详细描述
For patients included in the study, 40 mL of local anesthetic will be used for SIFIB. The local anesthetic concentration will be randomized using the biased-coin design up-down sequential method, as suggested by Durham et al. and described by Dixon.
The primer outcome of this study is block success. Also, the incidence of motor block formation in the quadriceps muscle (to be defined as paresis or paralysis in knee extension), the amount of tramadol needed in 24 hours, opioid-related side effects (postoperative nausea/vomiting, itching), length of hospital stay and complications that may develop related to the block will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
All blocks will be performed by the same experienced anesthetist to ensure block quality and homogeneity. The anesthetist applying the block will not take part in the patient follow-up, the independent assistant following the patient will be blinded to the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing arthroscopic knee surgery under spinal anesthesia will be included in the study.
排除标准
- •Conditions where regional anesthesia is contraindicated (coagulopathy, infection..)
- •Patients who underwent general anesthesia for the surgical procedure
- •Patients who do not want to be included in the study by not signing the voluntary consent form.
- •Patients with advanced dementia, orientation-cooperation problems
- •History of allergy to local anesthetic drugs
- •Infection status at the injection site
结局指标
主要结局
Block Success
时间窗: at 6, 12, 24 hours
Block success will be evaluated on the post-operative period in the antrior and lateral of thigh using pinprick test.
次要结局
- Tramadol Consumption(24 hours)