Predicting clinical entry point for thoracic epidural catheter insertion during para-median approach - A prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- To find correlation between a successful epidural puncture point to standard anatomical landmark – which includes the distance from midline, distance from upper and lower border of upper and lower spine of the desired space.
研究概览
简要总结
This is a prospective observational study to correlate the chances of success of paramedian approach of thoracic epidural catheter insertion with respect to standard landmarks mainly the distance with respect to spinal midline and from upper and lower border of upper and lower spine of the intended epidural space.
Primary objective is to find correlation between successful epidural puncture point to standard anatomical landmark – which includes the distance from midline, distance from upper and lower border of upper and lower spine of the desired space.
Secondary objectives are to note the number of attempts and number of passes in each attempt for locating epidural space, the failure rate of procedure ,other factors ( age,sex BMI ) affecting it.
Study methodology : For each attempt at the epidural space, an observer will record the number of attempts and passes and the performing anaesthesiologist will convey to the observer the most suitable option with respect to available landmarks choosen. Once the catheter is placed, the observer with the measuring tape will record the distance from midline with the help of measuring tape .The attempt will be marked as successful only after confirmation of anaesthetic band in the postoperative period.
Parameters to be recorded: • Factors that can affect the epidural outcome including age, sex, BMI, the landmarks • The total number of passes for the successful puncture point & total number of attempts taken will be noted. • Final outcome of epidural catheter insertion attempt abandoned / successful/ failure
Statistical Analysis: Primary end point – success will be compared with various end points using Chi square or Fischer exact test . For secondary outcomes, Chi square test will be used for categorical variable and student t test for continuous data
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients > 18 years of age, undergoing thoracic or abdominal surgeries under general anaesthesia with epidural analgesia attempted at the mid thoracic level T5-T8.
排除标准
- •Obvious spine deformities (or kypo/ scoliosis) Previous spine surgeries.
结局指标
主要结局
To find correlation between a successful epidural puncture point to standard anatomical landmark – which includes the distance from midline, distance from upper and lower border of upper and lower spine of the desired space.
时间窗: Immediate post operative period
次要结局
- 1. To note the number of passes needed to locate the space from the successful puncture point. 2. total number of attempts taken on an average to locate the epidural space, each fresh skin puncture being defined as an attempt. 3. Incidence of failed epidural (abandoned procedure, negative band on ice test postoperatively) 4. Other factors that affect epidural outcome – age, BMI, gender, ease of palpation of bony landmarks(Immediate post-operative period)