Epidural Neostigmine Dose Response for the Treatment of Labor Pain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Amount of Drug Consumed Per Hour in Each Group(Arm)
研究概览
简要总结
The purpose of this study is to see which dose of epidural neostigmine is the best additive to use with the numbing medication used in an epidural during labor.
详细描述
This study is examining the use of the non-narcotic medication, neostigmine, in combination with the local anesthetic bupivacaine when compared with the commonly used narcotic fentanyl in providing pain relief with the fewest side effects in labor 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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy pregnancy
- •Term pregnancy ( > 37 weeks)
- •Primiparous or multiparous
- •Induction or spontaneous labor greater or = 18 years of age
- •Cervical exam on entry </=5 cm
排除标准
- •Weight > 115 kg
- •Non-English speaking
- •IV analgesics within 60 minutes prior to epidural being administered
- •Allergy to local anesthetics or neostigmine
研究组 & 干预措施
Bupivacaine with Neostimgine 8 mcg/ml
STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
干预措施: Neostigmine (Drug)
Bupivacaine with Neostimgine 8 mcg/ml
STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
干预措施: Bupivacaine (Drug)
Bupivacaine and Neostigmine 4 mcg/ml
STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
干预措施: Neostigmine (Drug)
Bupivacaine and Neostigmine 4 mcg/ml
STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
干预措施: Bupivacaine (Drug)
Bupivacaine with Neostigmine 2 mcg/ml
STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
干预措施: Neostigmine (Drug)
Bupivacaine with Neostigmine 2 mcg/ml
STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
干预措施: Bupivacaine (Drug)
BUPIVACAINE WITH FENTANYL 2 MCG/ML
Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
干预措施: Bupivacaine (Drug)
BUPIVACAINE WITH FENTANYL 2 MCG/ML
Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
干预措施: fentanyl (Drug)
结局指标
主要结局
Amount of Drug Consumed Per Hour in Each Group(Arm)
时间窗: until delivery
Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)
次要结局
- Shivering(until delivery)
- Patient Satisfaction Scores(within 24 hours post delivery)
- Bromage Score(until delivery)
- Nausea(until delivery)
- Cesarean Delivery(occurence)
- Sedation(until delivery)
- Pruritus(until delivery)