A prospective randomized comparison of preprocedural ultrasound assisted standard paramedian and modified paramedian techniques for subarachnoid block in 50 years or above patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Comparison of number of attempts in standard paramedian approach needle insertion 1cm lateral and 1cm caudal to spinous process and modified paramedian approach with entry point 1cm lateral to spinous process
研究概览
简要总结
Title of the project: A Prospective randomized comparison of preprocedural ultrasound assisted standard paramedian and modified paramedian technique of subarachnoid block in patients 50 years or above.
Primary objective:
1Comparison of number of attempts of in standard paramedian approach (needle insertion 1cm lateral and 1cm caudal to spinous process) and modified paramedian approach with entry point 1cm lateral to spinous process.
2 Comparison of preprocedural ultrasound measured depth for needle insertion for spinal anaesthesia and actual depth of needle insertion while administrations of spinal anaesthesia using standard paramedian approach and modified paramedian approach.
3 Comparison of first attempt success rate in both paramedian groups.
Secondary objective:
1 Comparison of incidence of incidence of bloody tap in both groups.
2 Comparison of incidence of paraesthesia in both groups.
3 Comparison of incidence of post dural puncture headache in both groups within 24 hours postoperatively.
Spinal anaesthesia is most preferred technique for elderly patients with multiple comorbidities. Directing the needle into the vertebral canal is sometimes difficult in elderly patients because of narrow interspinous and interlaminar spaces. Preprocedural ultrasound scanning of spine before spinal anaesthesia help to overcome the common limitations like multiple attempts, postdural puncture headache, bloody tap and neurological injuries.
On reviewing the literature we could find that there is no consensus whether which approach is better or gold standard. There are many studies which comparing midline and paramedian approach but review of literature reveal very few or limited studies comparing preprocedural ultrasound assisted paramedian approach in elderly patients. Hence this particular study was undertaken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients 50 year or above posted for infra umbilical surgery and willing to participate in study.
排除标准
- •Patients refusal for spinal anaesthesia or unwilling to participate in the study Patients allergic to local anaesthetics Local infection or scarring at the site of needle insertion Patients with spinal deformities congenital or acquired and previous spine surgery Any history of bleeding disorders Any complication or adverse events during previous surgery under spinal anaesthesia Patients with morbid obesity.
结局指标
主要结局
Comparison of number of attempts in standard paramedian approach needle insertion 1cm lateral and 1cm caudal to spinous process and modified paramedian approach with entry point 1cm lateral to spinous process
时间窗: 0 minute
次要结局
- 1. Comparison of Preprocedural ultrasound measured depth for needle insertion for spinal anaesthesia and actual depth of needle insertion while administration of spinal anaesthesia using standard paramedian approach and modified paramedian approach(2. Comparison of first attempt success rate in both paramedian groups)