Randomized, Controlled, Double Blind, to Evaluate the Postpartum Analgesia With Epidural Morphine: Analgesic Effect of Two Different Doses Compared to Placebo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- The analgesic efficacy: : pain intensity rating
研究概览
简要总结
This study aims to assess the analgesic effect of two different doses of epidural morphine for postpartum analgesia management. Previous studies have shown that conventional management of postpartum pain (acetaminophen, NSAIDs) is insufficient, in the investigators country is wasted using the epidural catheter is placed as part of the analgesic management of pregnant women in labor.
详细描述
The intervention is the epidural administration of morphine in two doses 2mg and 3mg different vs placebo 1 hour after delivery care maternal vaginal in patients who received epidural analgesia in labor, in order to evaluate the analgesic effectiveness post operations of the different doses vs placebo.
In the analysis to determine whether the proposed levels are effective for postpartum pain control was carried out by determining the differences between experimental groups and control group, and in examining the statistical significance of the differences found by applying the relevant tests according to whether the variable is normally distributed or not.
The main variables analyzed were:
rating of pain intensity, number of analgesics required required dose of analgesics used to achieve adequate control pain, number of pain episodes and percentage of patients free of these episodes, duration of action of the dose used.
Similar analysis was determined by the incidence of side effects, in particular those described in classic form, pruritus, nausea and vomiting, urinary retention, and respiratory depression
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients postpartum vaginal conventional analgesia management of your labor
- •Do not include patients with history of allergy to morphine.
- •Patients who agreed to be included in the study but did not sign informed consent.
排除标准
- •Submit a complication that makes it difficult postoperative pain assessment or adverse effects after surgery.
- •Patients who, after having been included, express their desire to be excluded. Patients with incomplete follow-up.id
- •Did not include patients who have absolute contraindications for epidural anesthesia, or could not provide informed consent, as in the following cases: local infection at the site of administration, systemic infection, bleeding disorders, disease of the spine , mental patients, drug history, sleep apnea, history of headache post-puncture headache or frequent any kind.
研究组 & 干预措施
Morphine
Epidural Catheter morphine 2mg
干预措施: Morphine (Drug)
Placebo
Patients en treatment whit placebo, salIne solution in peridural cateter
干预措施: saline solution (Drug)
morphine
Epidurla cateter morphine 3 mg
干预措施: Morphine (Drug)
结局指标
主要结局
The analgesic efficacy: : pain intensity rating
时间窗: The first 24 hours after administration
The analgesic efficacy at controlling pain after delivery
次要结局
- the incidence of side effects(the first 24 hours after administration)