A Study to Evaluate the Effects of Epidural Lidocaine Administration on the Pharmacokinetic and Pharmacodynamic Profiles of DepoDur® (Morphine Sulfate Extended-release Injection) in Patients Undergoing Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of Extended Release Epidural Morphine (EREM)
研究概览
简要总结
To evaluate the levels of morphine in a patient's blood when morphine is given into the epidural space in the form of DepoDur® either alone or following a dose of lidocaine also given in the epidural space.
详细描述
To evaluate the levels of morphine in a patient's blood when morphine is given into the epidural space in the form of DepoDur® either alone or following a dose of lidocaine also given in the epidural space. Specifically, we are looking at pregnant women undergoing cesarean delivery who will be receiving these medications. A secondary objective is to evaluate how well DepoDur® works for pain control, as well as its safety, when it is given either alone or following a dose of epidural lidocaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria will include healthy parturients between the ages of 18 and 40 who have American Society of Anesthesiologists physical status I or II, have an uncomplicated, singleton, term pregnancy, and are scheduled to undergo cesarean delivery.
排除标准
- •Exclusion criteria for the study will included refusal to participate, American Society of Anesthesiologists physical status III or higher or any severe uncontrolled medical condition, significant systemic medical or obstetric disease, morbid obesity, opioid, Nonsteroidal Antiinflammatory Drug (NSAID), or local anesthetic allergy or intolerance, chronic analgesic or antidepressant use, accidental dural puncture, ineffective spinal or epidural, and conversion to general anesthesia.
研究组 & 干预措施
DepoDur following epidural lidocaine
Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
干预措施: DepoDur following epidural lidocaine (Drug)
DepoDur following spinal anesthetic
Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
干预措施: DepoDur following spinal anesthetic (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of Extended Release Epidural Morphine (EREM)
时间窗: a plasma sample at 0, 5, 10, 15, and 30 minutes, and 1, 4, 8, 12, 24, 36, 48, and 72 hours post-dose
The primary end point was to evaluate the pharmacokinetic profiles of EREM after either no epidural lidocaine or after an epidural lidocaine top-up for cesarean delivery.
次要结局
未报告次要终点