A Prospective Randomized Comparison of Fentanyl, Methadone and Morphine for Epidural Analgesia in an Experimental Pain Model
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Change in heat pain tolerance from baseline (using QST Medoc)
研究概览
简要总结
The aims of this study are to provide pharmacokinetic-pharmacodynamic data to quantify the analgesic and side effect profiles of epidural methadone, fentanyl and morphine. The investigators will compare the analgesic effect at three dermatomes to assess the rostral spread of drug, the investigators will assess plasma levels to assess the systemic redistribution of drug and the investigators will assess surrogate markers of central opiate effects (nasal capnography and pupilometry). The investigators hypothesize that due to the long-duration of action of methadone, and its intermediate lipophilicity, that methadone will provide a predominantly segmental analgesia of long duration of action, with low rostral spread and low direct central depressant effects (including respiratory depression).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (men and women) scheduled for extracorporeal shock wave lithotrypsy (for nephrolithiasis) under regional anesthesia.
排除标准
- •Inability to understand consent form; poor communication Refusal to sign consent form Contraindication to regional anesthesia Chronic opioid administration ASA classification 3 or greater Age < 18 or > 70
研究组 & 干预措施
Methadone
Epidural methadone bolus 4mg
干预措施: Epidural administration of bolus (Drug)
Morphine
Epidural morphine 4mg bolus
干预措施: Epidural administration of bolus (Drug)
Fentanyl
Epidural fentanyl 200 microgram bolus
干预措施: Epidural administration of bolus (Drug)
Saline
Epidural saline bolus
干预措施: Epidural administration of bolus (Drug)
结局指标
主要结局
Change in heat pain tolerance from baseline (using QST Medoc)
时间窗: At intervals: 30, 60, 90, 120, 180, 240, 300, 360, 410 min following drug and 24 hours following drug.
次要结局
- Change in electrical pain tolerance from baseline(At same time intervals as primary outcome)
- Plasma concentration of methadone, fentanyl, morphine (and metabolites)(At each of the time intervals as for primary endpoint)
- Pupilometry(At each of the time intervals as primary endpoint)
- Respiratory rate and arterial CO2 tension(At each of the time intervals as primary endpoint)