Ultrasound-assisted Versus Conventional Landmark-guided Paramedian Spinal Anesthesia in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- the number of needle passes
研究概览
简要总结
Multiple passes and attempts during spinal anesthesia might be associated with a greater incidence of paraesthesia, postdural puncture headache, and spinal hematoma. We hypothesized that the use of a preprocedural ultrasound-assisted paramedian technique for spinal anesthesia in patients with old age would reduce the number of passes required to entry into the subarachnoid space when compared with the landmark-guided paramedian approach. The study participants will be randomized into group L (landmark-guided) and group U (ultrasound-assisted). In group L, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. In group U, a preprocedural ultrasound scan will be used to mark the needle insertion site, and spinal anesthetic will be done via the paramedian approach.
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
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly patients (age≥60 years) scheduled to undergoing elective orthopedic surgery under spinal anesthesia
- •Patients 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 spine surgery
研究组 & 干预措施
Ultrasound-assisted
Ultrasound-assisted paramedian technique spinal anesthesia will be performed. A Preprocedural ultrasound scan will be performed for skin marking of entry site of spinal needle. Spinal anesthesia will be performed via paramedian approach using the skin marking site as entry point. 0.5% heavy bupivacaine will be administered into intrathecal space.
干预措施: Ultrasound-assisted paramedian technique spinal anesthesia (Procedure)
Ultrasound-assisted
Ultrasound-assisted paramedian technique spinal anesthesia will be performed. A Preprocedural ultrasound scan will be performed for skin marking of entry site of spinal needle. Spinal anesthesia will be performed via paramedian approach using the skin marking site as entry point. 0.5% heavy bupivacaine will be administered into intrathecal space.
干预措施: Ultrasound (Device)
Ultrasound-assisted
Ultrasound-assisted paramedian technique spinal anesthesia will be performed. A Preprocedural ultrasound scan will be performed for skin marking of entry site of spinal needle. Spinal anesthesia will be performed via paramedian approach using the skin marking site as entry point. 0.5% heavy bupivacaine will be administered into intrathecal space.
干预措施: 0.5% heavy bupivacaine (Drug)
Landmark-guided
In these patients, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. Landmark-guided paramedian technique spinal anesthesia will be performed. 0.5% heavy bupivacaine will be administered into intrathecal space.
干预措施: Landmark-guided paramedian technique spinal anesthesia (Procedure)
Landmark-guided
In these patients, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. Landmark-guided paramedian technique spinal anesthesia will be performed. 0.5% heavy bupivacaine will be administered into intrathecal space.
干预措施: 0.5% heavy bupivacaine (Drug)
结局指标
主要结局
the number of needle passes
时间窗: from the initiation of spinal anesthesia procedure, 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
- Periprocedural pain(from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection)
- Number of spinal needle insertion attempts(from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection)
- Time for identifying landmarks(from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection)
- Time taken for performing spinal anesthetic(from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection)
- Level of block(5, 10, 15 minutes after the completion of spinal anesthetic injection)
- Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle(from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection)
- Periprocedural discomfort score(from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection)
研究者
Jin-Tae Kim
Associate professor
Seoul National University Hospital