Midline Versus Paramedian Approaches for Ultrasound-assisted Spinal Anesthesia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- the number of needle passes
研究概览
简要总结
Ultrasound has emerged as an useful tool for neuraxial blockade. The aim of this study is to compare the efficacy and safety between the midline approach and paramedian approach for ultrasound-assisted spinal anesthesia in adult patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Adult patients scheduled to undergoing elective orthopedic surgery under spinal anesthesia, with ASA physical status classification I, II, III
排除标准
- •Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)
- •Patients with morbid cardiac diseases
- •Pregnancy
- •Patients with previous history of lumbar spinal surgery
- •Patients with anatomical abnormality of lumbar spine
研究组 & 干预措施
Midline group
Preprocedural ultrasound-assisted midline approach of spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
干预措施: ultrasound-assisted midline approach (Procedure)
Paramedian group
Preprocedural ultrasound-assisted paramedian approach of spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
干预措施: ultrasound-assisted paramedian approach (Procedure)
结局指标
主要结局
the number of needle passes
时间窗: Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
the number of forward advancements of the spinal needle in a given interspinous space, i.e., withdrawal and redirection of spinal needle without exiting the skin
次要结局
- Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle(Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection))
- Number of spinal needle insertion attempts(Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection))
- Time for identifying landmarks(intraoperative (time taken for establish the landmark, from start of US scanning to completion of scanning)
- Time taken for performing spinal anesthetic(Intraoperative (from insertion of the needle to the completion of injection))
- dermatome level of sensory block(20 minutes after the completion of spinal anesthetic injection)
- Periprocedural pain(Patients will be asked immediately after the completion of spinal anesthesia)
- Periprocedural discomfort score(Patients will be asked immediately after the completion of spinal anesthesia)
- Patient satisfaction score of spinal anesthesia procedure(Patients will be asked immediately after the completion of spinal anesthesia)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital