Comparison Between Real-Time Ultrasound Guidance vs Anatomical Landmark Technique on the Efficacy of Paramedian Spinal Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- success rate of spinal needle insertion
研究概览
简要总结
The purpose of this study is to compare the clinical efficacy of real-time ultrasound guidance on spinal anesthesia vs the traditional anatomical landmark technique, by comparing success rate of spinal needle insertion, success rate rate of single needle pass, duration and immediate complications.
详细描述
Research hypothesis
- Ultrasound guidance will lead to a significantly different success rate of paramedian spinal needle insertion, as well as the success rate of single-needle-pass when patient lying in lateral position.
- Ultrasound guidance of paramedian spinal anaesthesia has a different rate of complication of spinal anaesthesia, e.g. postdural puncture headache and bloody taps.
- Ultrasound guidance of paramedian spinal anaesthesia will cause a significant different in duration of giving spinal anaesthesia, compared to non ultrasound guided technique.
Justification of the Study
Ultrasound guidance in neuraxial blockade has been shown to be superior to palpation in correctly identifying lumbar intervertebral level, as well as improve efficiency and reduce complication of spinal anaesthesia.
Paramedian approach to the subarachnoid spaces is useful in situations where the patient's anatomy does not favor the midline approach, e.g., inability to flex the spine or heavily calcified interspinous ligaments. Studies have shown that choice of midline or paramedian approach did not affect the success rate of the subarachnoid puncture in general. Therefore, this is a technique that worth to be studied.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consented adults aged at least 18 years old.
- •ASA I to III.
- •Presented for lower limb surgery.
- •Fasted for at least 6 hours.
排除标准
- •Patient refusal
- •Contraindication to neuraxial block.
- •Patient on anticoagulant medication, or coagulopathy (INR > 1.5)
- •Patient on double antiplatelet, or thrombocytopenia (platelet < 100)
- •Local infection at site of injection
- •Indeterminate neurological disease
- •Allergy to local anaesthetics
- •Spinal abnormality
- •Pregnancy.
- •Previous surgery to lumbar region.
- •BMI > 30
结局指标
主要结局
success rate of spinal needle insertion
时间窗: during the procedure of spinal anesthesia
The ability of getting a successful spinal anesthesia with a single skin puncture regardless of needle redirection.
success rate of single needle pass
时间窗: during the procedure of spinal anesthesia
The ability of getting a successful spinal anesthesia with a single skin puncture and no needle redirection.
次要结局
- duration of procedure(during the procedure of spinal anesthesia)
- immediate complication(immediately after and within 1 week after given spinal anesthesia)
研究者
Soon Eu Chong
Medical Lecturer in Anesthesiology
Universiti Sains Malaysia