How Sweet is it? Measurement of Glucose in Epidural Fluid and Fluid Obtained During Spinal Anesthesia After a Failed Epidural Using a Bedside Monitor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- To confirm that the glucose meter is a feasible and accurate bedside method to detect glucose in epidural aspirate and to use glucose to differentiate CSF from epidural aspirate in women with pre-existing epidural catheters.
研究概览
简要总结
When a woman requires a cesarean section after labour, anesthesia is usually provided by a pre-existing epidural. Occasionally, the epidural does not work. The anesthesiologist then may give a "spinal anesthetic". The spinal space is identified by seeing cerebrospinal fluid (CSF) in the spinal needle. Rarely a spinal fails after a failed epidural as the fluid seen is epidural space fluid, not CSF. This study plans to use a bedside glucose monitor to measure glucose (sugar) in epidural fluid (compared to CSF) allowing the anesthesiologist to know the spinal needle is in the correct space.
The investigators hypothesize that a bedside glucose measurement device can accurately quantitate the level of glucose within epidural space aspirate, and therefore could aid differentiation between CSF and epidural fluid.
详细描述
It would be clinically useful to have a bedside test to confirm that the fluid obtained during insertion of a spinal needle following a failed epidural is, in fact, CSF prior to the injection of local anesthetic. This test also may decrease the probability of a failed spinal following a failed epidural top up, and therefore avoid the risks of general anesthesia in the parturient.
When a cesarean delivery is required following a trial of labour, an epidural catheter in situ can be used to provide surgical anesthesia. A large volume (10-20 milliliters) of local anesthetic is administered through the epidural catheter. This is aimed to produce a dense nerve block up to T4 (nipple level), which is sufficient for lower abdominal surgery.
Occasionally, however, this technique does not provide adequate anesthesia for a surgical intervention - termed a 'failed epidural top-up' - and this is estimated to occur up to 38% of the time. Options following the failure of an epidural top-up are dependent on the urgency of delivery, and include either a general anesthetic or an intrathecal injection of local anesthetic (a 'spinal'). The preferred choice for both mother and baby, if time allows, is normally considered to be a spinal.
A spinal is performed by inserting a needle into the subarachnoid space which is surrounded by the epidural space. The subarachnoid space contains CSF, the spinal cord and exiting nerves from the spinal cord. The anesthesiologist identifies the subarachnoid space by obtaining CSF through the needle. Local anesthetic can then be injected directly into the space.
Rarely, spinal anesthesia may fail when administered following a failed epidural, and there are several theories as to why this may occur.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women (American Society of Anesthesiologists (ASA) 1 or 2 classification) with a pre-existing epidural. This will include women with uncomplicated disorders of glucose metabolism e.g. gestational diabetes, insulin dependent gestational diabetes and insulin dependent diabetes.
- •Singleton pregnancy
- •Age 19 years or older
- •Understand written and oral English
排除标准
- •Emergency cesarean delivery where time would not allow full consent or sampling
结局指标
主要结局
To confirm that the glucose meter is a feasible and accurate bedside method to detect glucose in epidural aspirate and to use glucose to differentiate CSF from epidural aspirate in women with pre-existing epidural catheters.
时间窗: Between 2-24 hours after labouring woman has an epidural placed for her labour
Descriptive statistics outlining the range, central tendency (mean, median), and variability (standard deviation) for epidural glucose will be presented, and these figures then compared to those obtained from the Sweet CSF study.
次要结局
- Influence of other factors on epidural glucose(Between 2-24 hours after labouring woman has an epidural placed for her labour)