NCT03491943已完成不适用
Midline Versus Paramedian Approaches for Ultrasound-assisted Spinal Anesthesia: a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 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
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
- Number of spinal needle insertion attempts(Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection))
- 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))
- 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
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Comparison of Ultrasound-Guided Classic And Lateral Approach Thoracolumbar Interfascial Plane BlockLumbar Disc HerniationNCT03854240Medipol University60
已完成
不适用
Diffusion of Local Anesthetic After Median Nerve BlockMedian NerveNCT00651170Hopital Foch103
招募中
不适用
Comparison of Ultrasound-Guided Injection With Median Nerve Decompression Surgery in Carpal Tunnel SyndromeMusculoskeletal DiseasesMedian Nerve DiseaseUltrasound-Guided InjectionSurgeryCarpal Tunnel SyndromeNCT06243848Afyonkarahisar Health Sciences University60
尚未招募
3 期
To compare different approaches for spinal anaesthesia in adults undergoing elective surgeryCTRI/2022/02/040371Vardhman Mahavir Medical college and Safdarjung hospital
已完成
不适用
Medial Versus Lateral Approach in Ultrasound (US)-Guided Supraclavicular BlockHand or Arm SurgeryNCT00992810University Health Network, Toronto78