Thoracic Epidural Analgesia: Epidural Levobupivacaine and Sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Efficacy of the analgesic regimen
研究概览
简要总结
Thoracic epidural analgesia is often proposed to thoracotomized patients. A local anesthetic and an opioid are generally associated to produce an epidural analgesia. However, opioid epidural administration is frequently associated with adverse effects as nausea, vomiting, urinary retention, ... On the other hand, iv ketamine has been demonstrated to be an effective analgesic.
The purpose of the study is to compare the epidural administration of levobupivacaine and sufentanil or the epidural administration of levobupivacaine associated with the iv administration of ketamine.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 75 yrs
- •class ASA I, II or III
- •lung surgery
排除标准
- •Contra-indication to the achievement of epidural analgesia
- •Preoperative chronic pain,
- •Contra-indication to ketamine
- •Hypersensitivity to ketamine or any excipients
- •Uncontrolled hypertension,
- •Heart failure
- •Hepatic porphyria
- •Contra-indication to sufentanil
- •Hypersensitivity to sufentanil, opioids or any excipients
- •Treatment with an opioid agonist-antagonist,
- •Contra-indication to levobupivacaine
- •Hypersensitivity to levobupivacaine, local anesthetics of the amide or any excipients
- •Hypotension, shock
研究组 & 干预措施
iv Ketamine
Epidural infusion of levobupivacaine and saline (placebo for sufentanil)and iv infusion of ketamine Up to the third postoperative day (6 PM)
干预措施: Ketamine (Drug)
Sufentanil
Epidural infusion of levobupivacaine (1,25 mg/ml) and sufentanil(1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of saline (placebo for ketamine)
干预措施: Sufentanil (Drug)
结局指标
主要结局
Efficacy of the analgesic regimen
时间窗: third postoperative day
Occurrence of an adverse event due to the analgesic protocol
时间窗: one week
次要结局
- postoperative complications (pulmonary, others)(one month)
- length of stay(one month)
- patient's satisfaction(sortie de l'hopital)
- Occurence of a chronic pain(end the first postoperative year)
- postoperative rehabilitation(two weeks)