Analgesia Requirement and Maternal Satisfaction Following Epidural PCA in Nulliparous Labor: the Effect of a Four-Fold Change in Local Anesthetic Concentration.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1. Anesthesia requirement:
研究概览
简要总结
This study studies labor epidural analgesia and compares dilute (0.0625%) with concentrated (0.25%) bupivacaine.
We hypothesize that patients randomize to receive the concentrated drug will require more drug, will have a more profound motor block, will be more likely to require instrumental delivery and will be less satisfied than those receiving dilute epidural drugs.
详细描述
This study examines the effect of two different local anesthetic concentrations used for epidural analgesia in labor. Patients are randomized to receive epidural bupivacaine, either as a concentrated (0.25%), or a dilute (0.0625%) solution, both administered by patient-controlled epidural analgesia (PCEA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •nulliparity, active spontaneous labor, cervical dilatation greater than 2cm and less than 5 cm, request for epidural analgesia, age between 18 to 40, American Society of Anesthesiologists (ASA) physical status I or II, body weight less than 110kg, gestational age greater than 36 completed weeks, singelton pregnancy and vertex presentation
排除标准
- •narcotic administration in the previous 3 hours, non-reassuring fetal heart rate tracing at any stage in labor prior to enrollment, previous uterine surgery, pre-eclampsia and the inability to adequately understand the consent process.
结局指标
主要结局
1. Anesthesia requirement:
a. total dose (mg) of bupivacaine administered
b. number of supplemental bolus doses of bupivacaine self-administered (by PCEA)
c. total number of attempts for supplemental bupivacaine doses (including those denied)
次要结局
- 1. Maternal satisfaction (visual analogue scale (VAS) with the anchors being 0 = maximally satisfied and 100 = maximally dissatisfied); after delivery and at 24 hours.
- 2. Speed of onset of analgesia.
- 3. Anesthesia variables (in labor q 1hr)
- a. Pain score VAS during uterine contraction
- b. sensory level
- c. motor power
- d. maternal blood pressure.
- 3.Obstetric outcome variables
- a. 1st stage duration
- b. 2nd stage duration
- c. Expulsive efforts
- d. Apgar scores at 1 and 5 min
- e. Instrumental delivery
- f. Cesarean section
- g. Non-reassuring fetal heart rate tracing in labor
- h. Occipito-posterior malrotation