Which Position is Best: A Randomized Clinical Trial on the Effect That Position Has on Walking Labour Epidural Analgesia
试验速览
- 阶段
- 不适用
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Labour pain based on verbal rating pain scale
研究概览
简要总结
This study is being done to better understand how patient positioning can affect pain relief after an epidural. In addition to pain, the investigators will assess how position affects epidural spread, and its effects on maternal blood pressure and fetal heart rate.
详细描述
Epidurals will be placed with parturients in the standard sitting position. An epidural catheter will be placed to a depth of 5 cm into the epidural space. After placement, parturients will be randomized to one of the four position groups (left uterine displacement, left lateral, right lateral, or seated upright). After successful positioning, a series of 5 cc bolus doses of 0.08% ropivacaine with 2 mcg per cc of fentanyl will be injected through the epidural catheter in 5 minute intervals for a total volume of 20 cc. After the initial loading dose of epidural solution has been injected in the first 20 minutes post-insertion, the patient will be able to return to whatever position they are most comfortable with. The parturient will be asked to rate their pain on a verbal pain scale of between 0 and 10 at the peak of their contraction at three time intervals. The spread of the blockade will be assessed with ice applied along both the left and right mid-clavicular lines. Maternal blood pressure will be measured on the upper arm in all patients as per nursing protocol. Fetal heart rate will be monitored intermittently with Doppler ultrasound as per nursing protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Active labour or admitted for induction of labour
- •Requesting an epidural for labour analgesia
- •Contractions occurring greater than once every 5 minutes
排除标准
- •Coagulation disorder
- •High risk pregnancy as per obstetrics
- •Spinal pathology (included scoliosis, herniated disks, or previous lumbar back surgery)
结局指标
主要结局
Labour pain based on verbal rating pain scale
时间窗: Taken at time 40 minutes after epidural insertion
Pain with contractions, assessed using a 0 to 10 verbal rating pain scale; 0 being no pain with a contraction and 10 being the worse pain with a contraction.
次要结局
- Category of epidural based on bilateral dermatome levels(Taken at time 40 minutes after epidural insertion)
- Assessment of epidural levels based on dermatomes(Taken at time 40 minutes after epidural insertion)
- Events of maternal hypotension after epidural placement(Blood pressure taken with a non-invasive blood pressure monitoring cuff every 5 minutes for 20 minutes after epidural insertion)
- Events of fetal bradycardia after epidural placement(Intermittent fetal heart rate monitoring via doppler as per nursing protocol for 20 minutes after epidural insertion)
研究者
Monica San Vicente
Principal Investigator
University of Saskatchewan