A Prospective, Randomized Controlled Trial Evaluating the Diagnostic Utility of the Swirl Sign for Epidural Catheter Placement Confirmation in Adult Surgical Patients (The EPICS Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the swirl sign for confirming correct epidural catheter placement (sensitivity, specificity, positive predictive value, negative predictive value).
研究概览
简要总结
This prospective, randomized controlled trial aims to evaluate the diagnostic accuracy of the swirl sign for confirming correct epidural catheter placement in adult surgical patients. Sixty patients scheduled for elective surgeries under combined spinal-epidural anesthesia will be randomized into two groups. In the study group, the swirl sign will be used to confirm catheter placement; in the control group, traditional methods such as test dose and aspiration will be used. The primary outcome is the diagnostic accuracy of the swirl sign compared to the reference standard of successful block. Secondary outcomes include time taken for confirmation, number of attempts, and incidence of complications. The study will be conducted at a single tertiary care hospital in India over a period of six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (ASA I–III) undergoing elective surgeries under epidural anesthesia who provide informed consent.
排除标准
- •Patients with coagulopathy, local infection at puncture site, spinal deformity, prior spine surgery, allergy to local anesthetics, pregnancy, inability to provide informed consent, or requiring combined spinal-epidural anesthesia.
结局指标
主要结局
Diagnostic accuracy of the swirl sign for confirming correct epidural catheter placement (sensitivity, specificity, positive predictive value, negative predictive value).
时间窗: 1. Immediately after epidural catheter placement confirmation (baseline). | 2. At 5 minutes post-catheter placement. | 3. At the end of the procedure.
次要结局
- Time taken for confirmation of correct catheter placement(immediately after insertion.)
- Number of attempts for catheter placement(Intraoperative)
- Incidence of failed epidural block(within 30 minutes after drug administration.)
- Complications related to catheter placement (e.g., dural puncture, intravascular placement)(Intraoperative)
研究者
Dr Gautham Patel
HOSMAT Multispeciality Hospital