A Phase 1 Study to Evaluate the Effects of Lidocaine/Epinephrine Test Dose Administration on the Pharmacokinetic Profile of a Single Dose of Thoracic Extended-Release Epidural Morphine in Patients Undergoing Major Upper Abdominal Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 主要终点
- Evaluate the serum pharmacokinetic profile of a single 15-mg dose of DepoDur administered at the lower thoracic epidural space with or without a prior lidocaine-epinephrine test dose
研究概览
简要总结
The primary purpose of this study is to evaluate the effects of lidocaine/epinephrine test dose administration on the PK profile of a single epidural dose of DepoDur (extended-release epidural morphine) in patients undergoing major upper abdominal surgery. A secondary objective was to evaluate the safety and efficacy profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥ 18 years of age at Screening
- •Negative pregnancy test in females of childbearing potential
- •Scheduled for major upper abdominal surgery via an upper midline incision under general anesthesia
- •American Society of Anesthesiology (ASA) Physical Class 1, 2, or 3
- •Willing and able to use a PCA pump
- •Willing to receive only IV fentanyl for 72 hours post-dose to control post-operative pain
- •Capable of providing written informed consent and responses to pain assessment scales and neurological assessment questionnaires
排除标准
- •Morbid obesity, defined as a body mass index (BMI) ≥ 40
- •Scheduled to undergo surgery under regional anesthesia
- •Usage of analgesic medications containing morphine or codeine within three days prior to study drug administration
- •Chronic opioid medication usage (defined as daily opioids for more than 7 days prior to enrollment)
- •Suspected or documented history of sleep apnea, narcolepsy, or excessive daytime sleepiness
- •Female who was pregnant or lactating
- •History of hypersensitivity or idiosyncratic reaction to opioid medications, local anesthetics, or epinephrine
- •Any contraindication for the epidural administration of study drug (e.g., coagulopathy, local infection)
- •Administration of an investigational drug within 30 days prior to Screening
- •Suspected or documented history of substance abuse and/or alcoholism
- •Any contraindication to frequent blood PK sampling (such as significant anemia) or other barrier to obtaining timely PK samples
研究组 & 干预措施
1
No test dose + DepoDur + flush with 1 mL normal saline
干预措施: DepoDur (extended-release epidural morphine) (Drug)
2
Test dose + flush with 1 mL normal saline + 3-minute wait + DepoDur + flush with 1 mL normal saline
干预措施: DepoDur (extended-release epidural morphine) (Drug)
3
Test dose + flush with 1 mL normal saline + 10-minute wait + DepoDur + flush with 1 mL normal saline
干预措施: DepoDur (extended-release epidural morphine) (Drug)
4
Test dose + flush with 1 mL normal saline + 15-minute wait + DepoDur + flush with 1 mL normal saline
干预措施: DepoDur (extended-release epidural morphine) (Drug)
5
Test dose + No flush + 3-minute wait + DepoDur + flush with 1 mL normal saline
干预措施: DepoDur (extended-release epidural morphine) (Drug)
结局指标
主要结局
Evaluate the serum pharmacokinetic profile of a single 15-mg dose of DepoDur administered at the lower thoracic epidural space with or without a prior lidocaine-epinephrine test dose
次要结局
- efficacy and safety profiles