Epidural Dexamethasone for Labor Analgesia: the Effects on Ropivacaine Consumption and Labour Outcome. A Randomized Double Blind Placebo Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Hourly ropivacaine consumption expressed as mg/mL used during epidural analgesia in parturient women
研究概览
简要总结
To assess the efficacy of epidural dexamethasone administration, compared to placebo, in reducing local anesthetics consumption during labor epidural analgesia in parturient women
详细描述
It is hypothesized that reducing the consumption of local anesthetics during labor epidural analgesia could lower their side effects (rate of motor block, nausea and emesis during labor, maternal hypotension, maternal fever) and improve the duration of the second part of the labor, and the new-born adaptation to child-birth and during the first 24 hours. The use of instruments for assisted vaginal delivery and the needs to perform emergency cesarean could also be impacted.
The efficacy of the dexamethasone will be assessed by the hourly Ropivacaine consumption (milligrams/hour) measured from randomization time to the end of epidural analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •First and single pregnancy, Full term (> 37 wks amenorrhea), Cephalic presentation, Spontaneous labor, Epidural analgesia requested by the parturient
排除标准
- •Minor patient, Planned cesarean section, Gestational hypertension and preeclampsia, Gestational diabetes, opioids or ocytocin administration before epidural analgesia preparation, Allergy to dexamethasone, Untreated gastroduodenal ulcer, epidural analgesia contraindications
研究组 & 干预措施
Epidural analgesia + DEXAMETHASONE
Single epidural injection of Dexamethasone Mylan (8 mg) concomitant to epidural analgesia (ropivacaine+ sufentanil)
干预措施: Dexamethasone (Drug)
Epidural analgesia + DEXAMETHASONE
Single epidural injection of Dexamethasone Mylan (8 mg) concomitant to epidural analgesia (ropivacaine+ sufentanil)
干预措施: Ropivacaine (Drug)
Epidural analgesia + DEXAMETHASONE
Single epidural injection of Dexamethasone Mylan (8 mg) concomitant to epidural analgesia (ropivacaine+ sufentanil)
干预措施: Sufentanil (Drug)
Epidural analgesia + PLACEBO
Single epidural injection of sodium chloride (0.9%) Lavoisier concomitant to epidural analgesia (ropivacaine + sufentanil)
干预措施: Placebo (Drug)
Epidural analgesia + PLACEBO
Single epidural injection of sodium chloride (0.9%) Lavoisier concomitant to epidural analgesia (ropivacaine + sufentanil)
干预措施: Ropivacaine (Drug)
Epidural analgesia + PLACEBO
Single epidural injection of sodium chloride (0.9%) Lavoisier concomitant to epidural analgesia (ropivacaine + sufentanil)
干预措施: Sufentanil (Drug)
结局指标
主要结局
Hourly ropivacaine consumption expressed as mg/mL used during epidural analgesia in parturient women
时间窗: From the beginning to the end of epidural analgesia, that could last up to 6 hours
The administered dose of ropivacaine during epidural is used to measure the efficacy of Dexamethasone in reducing local anesthetics during labor analgesia
次要结局
- Dexamethasone effect maternal pain during delivery assessed by Visual Analogic Scale(From the beginning to the end of epidural analgesia, that could last up to 6 hours)
- Improvement of delivery assessed by recording the number of side events (motor block, emergency cesarean, instrument-assisted delivery)(From the beginning to the end of epidural analgesia, that could last up to 6 hours)
- Improvement of epidural analgesia assessed by the reduction of adverse effects induced by local anesthetics(From the beginning to the end of epidural analgesia, that could last up to 6 hours)
- Maternal satisfaction assessed by visual analogic scale(On the morning of the next day after delivery, up to 24 hours)