Dexmedetomidine , Fentanyl or Nalbuphine As Additives to Epidural Bupivacaine for Labor Analgesia. A Double Blind Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 69
- 主要终点
- VAS score for pain
研究概览
简要总结
The aim of the study will be to compare the role of Dexmedetomidine, Nalbuphine and fentanyl as additives to epidural bupivacaine in painless vaginal delivery as regard of effectiveness analgesia and maternal safety.
详细描述
Labor pain often causes a strong stress response. Several inhalation and parenteral anesthetics, sedatives, tranquilizers, and analgesics have been used for pain relief during labor, while over the last decade, lumbar epidural analgesia has greatly increased .
Recently, it was concerned by most mothers and doctors that how to alleviate the pain during delivery. The ideal labor analgesia should be based on maternal and child safety and should have a fast acting good analgesic effect and less adverse reaction .
Epidural anesthesia is convenient and has a less adverse reaction and obvious effect in the commonly used analgesic methods, which are widely used in the current way of analgesia .
Studies have confirmed the efficacy of dexmedetomidine in prolonging the duration of perineural nerve blocks. Specifically, perineural dexmedetomidine enhances sensory, motor, and analgesic block characteristics.
Dexmedetomidine is a selective α₂ receptor agonist and has a sympatholytic, sedative, and opioid sparing effect. It does not cause respiratory depression and can therefore be used as an adjuvant in certain clinical settings .
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •>/= 18 years of age
- •American Society of Anesthesiologists (ASA) Physical Status 2 or 3
- •Full term pregnancy (>37 gestational weeks)
- •Planning vaginal delivery
- •Planning epidural labor analgesia
- •Vertex presentation
排除标准
- •Patient refusal to epidural analgesia,
- •Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity)
- •Allergy to study agents (hypersensitivity to bupivacaine, Nalbuphine, fentanyl or dexmedetomidine)
- •hemodynamic instability, severe aortic or mitral stenosis)
- •Severe pre-eclampsia,
- •Breech presentations
- •Antepartum hemorrhage
- •Cephalopelvic disproportion
- •Body mass index ≥40 kg/m
- •Uncontrolled systemic comorbidities [i.e., diabetes, hepatic, renal or cardiac]
- •Known or suspected fetal abnormalities
- •Inability to communicate or participate in study procedures
研究组 & 干预措施
epidural Bupivacaine with Dexmedetomidine in normal labor
Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with Dexmedetomidine 0.5 μg/ml
干预措施: Dexmedetomidine (Drug)
epidural Bupivacaine with fentanyl in normal labor
Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with fentanyl 2 μg/ml.
干预措施: fentanyl (Drug)
epidural Bupivacaine with Nalbuphine in normal labor
Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with 0.2 mg/ml Nalbuphine.
干预措施: Nalbuphine (Drug)
结局指标
主要结局
VAS score for pain
时间窗: before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.
changes in VAS score for pain before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.
次要结局
未报告次要终点
研究者
Abanob Fathy Zareef
Resident
Assiut University