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临床试验/CTRI/2024/11/077029
CTRI/2024/11/077029尚未招募不适用

Comparison of efficacy of ultrasound guided and conventional landmark technique in patients with difficult spine predictors for spinal anesthesia: open RCT

All India Institute of Medical SciencesBibinagar1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2024年11月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
170
试验地点
1
主要终点
Compare the first attempt success rate between the two groups

研究概览

简要总结

Neuraxial procedures are traditionally blind techniques where space is identified by palpation of anatomic landmarks namely iliac crests and spinous processes together with tactile feedback during needle  insertion and loss of resistance confirming entry into subarachnoid space. But the technical difficulty of neuraxial blockade correlates with the quality of palpable surface landmarks. Palpation is often inaccurate and these surface landmarks may be absent, indistinct or distorted in many adult patients because of obesity, previous spinal surgery, deformity or degenerative changes of aging, insufficient gap between the spinal vertebrae, skin distances from the subarachnoid space, size of the needles; therefore, failed blocks and complications are common.

Repeated attempts and redirections of the needle may lead to nerve injury, spinal hematoma, post dural puncture headache and added discomfort to the patient. Multiple case reports demonstrate the utility of ultrasound in guiding neuraxial blockade in patients with difficult spinal anatomy. Ultrasound imaging provides information about the accurate intervertebral level of puncture, optimal needle insertion point and depth of needle advancement for a successful neuraxial block. But there has been only few RCTs in the Indian scenario on the subject. Therefore, we designed a study aimed to compare the efficacy between the preprocedural ultrasound assisted technique and the conventional landmark based technique in patients with predictors of difficult spinal posted for elective surgery under spinal anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with difficult spinal predictors Elective surgery requiring Spinal Anesthesia ASA 1 and 2.

排除标准

  • Patients with severe cardiopulmonary diseases contraindications of spinal anesthesia inability to communicate/co-operate.

结局指标

主要结局

Compare the first attempt success rate between the two groups

时间窗: Within 5 minutes after completion of the procedure. There is only one time point as no serial measurements will be taken.

次要结局

  • 1.Number of needle redirections(2.Number of attempts (including number of redirections & new needle insertions).)

研究者

发起方
All India Institute of Medical SciencesBibinagar
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sushmitha

All India Institute of Medical Sciences, Bibi Nagar

研究点 (1)

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