The Effects of Dural Puncture Epidural Versus Combined Spinal Epidural With Epidural Volume Extension Techniques on Birth Variables in Labor Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- First Epidural top-up time
研究概览
简要总结
Labor is the process where the cervix is prepared to allow the baby to pass from the uterine cavity to the outside world. In the ordinary course, it ends with spontaneous or instrumental vaginal delivery or cesarean section. Traditionally, the first stage in which the cervix is passively dilated in response to uterine contractions consists of the second stage in which the mother passes the baby through the vagina and the third stage, the exit of the placenta.
In the first stage of labor, pain is caused by uterine contractions and pressure on the cervix. Pain is transmitted through the T10-L2 spinal nerves and is felt in the abdominal wall, waist, hips, or thighs. In the second stage, pain from the vagina and perineum is added to uterine pain. This pain is transmitted by the pudendal nerves through the S2-4 nerve roots.
In this study, we aimed to investigate the effects of dural puncture epidural analgesia versus combined spinal-epidural analgesia with epidural volume extension on labor variables.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I and II parturients
- •Pregnant patients in active labor
- •active labor with cervical dilation < 5cm
- •37-42 weeks of gestational age
- •Pregnant women between the ages of 18 and 45
排除标准
- •Patients who do not want to participate voluntarily in the study
- •Pregnant women outside the age range of 18 - 45
- •Pregnants other than Nullipar
- •Patients with allergic reactions to anesthesia and analgesia drugs to be used
- •Severe systemic disease (kidney, liver, pulmonary, endocrine, cardiac)
- •Gestational comorbidity (preeclampsia, eclampsia, diabetes mellitus, etc.)
- •Substance abuse history
- •Chronic pain history
- •Psychiatric problems and communication difficulties
- •BMI> 35 kg / m2
- •Failure in neuraxial interventions
研究组 & 干预措施
Dural puncture epidural
2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural
干预措施: Epidural (Drug)
Combined spinal-epidural with epidural volume extension
10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural
干预措施: Intrathecal+Epidural (Drug)
结局指标
主要结局
First Epidural top-up time
时间窗: First 24 hours
Time elapsed between the end of local anesthetic injection and the return of pain \>4 on the NPRS.
次要结局
- Sacral analgesia time(First 24 hours)
- Performance time(First 24 hours)
- Incidence of Side Effect(First 24 hours)
研究者
Muhammed E Aydin
Principal Investigator
Ataturk University