A Prospective Double Blind Randomized Comparison of Methadone, Fentanyl, and Morphine for Post-laparotomy Epidural Analgesia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Variable stimuli, fixed response: measurement of pain tolerance by gradual increase of temperature (quantitative sensory testing (QST))as compared to baseline
研究概览
简要总结
The current study aim is to compare between the opioids morphine, fentanyl and methadone in terms of efficacy and side effects profile when administered epidurally for pain management after laparotomies. Intravenous morphine will also be used. The outcomes of that method will be compared to those obtained using epidurally administered opioids, as this is another commonly used postoperative pain relief method.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Elective laparotomy
排除标准
- •Subjects with diabetes mellitus, other neurological or systemic disease associated with altered sensory perception
- •Illicit drug abusers
- •Chronic use of pain medication
- •Inability to understand consent form
- •Age < 18
- •Renal failure (Clcr<50 ml/min)
- •Chronic use of drugs that can alter plasma levels and\or effect of the study drugs
- •Corrected Q-T interval(QTc)=450msc and above
- •Contra-indication for epidural catheter insertion
- •Pregnancy
研究组 & 干预措施
morphine, epidural
Epidurally administrated morphine
干预措施: epidural morphine via PCEA (Drug)
fentanyl, epidural
epidurally administrated fentanyl
干预措施: epidural fentanyl via PCEA (Drug)
methadone, epidural
epidurally administrated methadone
干预措施: epidural methadone via PCEA (Drug)
morphine, intervenous
intravenously administrated morphine
干预措施: intravenous morphine via PCA (Drug)
结局指标
主要结局
Variable stimuli, fixed response: measurement of pain tolerance by gradual increase of temperature (quantitative sensory testing (QST))as compared to baseline
时间窗: 72 hours post operatively
Fixed stimuli, variable response: measurement of reaction to fixed temperature by visual analog scale (VAS) as well as Variable stimuli, variable response (electrical stimuli)as compared to baseline.
时间窗: 72 hours post operatively
patient controlled epidural analgesia (PCEI)/patient controlled analgesia (PCA)dose frequency as compared to baseline
时间窗: 72 hours post operatively
次要结局
- Measurement of opioid concentration in plasma as compared to baseline(Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery)
- Pupillometry as compared to baseline(Baseline and twice daily for 72 hours starting 18-24 hours post surgery)
- Respiratory rate as compared to baseline(Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery)
- Nasal capnography at rest as compared to baseline(Baseline and twice daily for 72 hours starting 18-24 hours post surgery)
- Report of adverse effects' severity as compared to baseline(Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery)
- Report of pain severity- at rest, cough and deep breathing as compared to baseline(Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery)