Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- the Extent of Hyperalgesia Area Proximal to Surgical Wound
研究概览
简要总结
Background: In perioperative period inhibition of N-Methyl-D-Aspartate receptor prevents opioid-induced hyperalgesia and reduce postoperative opioid requirement after abdominal surgery. Methadone is both a µ-opioid receptor agonist like Morphine and a N-Methyl-D-Aspartate antagonist. Study Aim. To evaluate the efficacy of intraoperative Ketamine and postoperative Methadone analgesia in preventing opioid-induced hyperalgesia after abdominal surgery.
详细描述
not desired
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
- Double (Participant, 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
- •patients undergoing open colo-rectal surgery
排除标准
- •ASA status more than II, history of chronic pain, ischemic heart disease or chronic pulmonary disease, allergy to any drugs used in the protocol. Body Max Index more than 35.
研究组 & 干预措施
ketamine/morphine
Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery.
干预措施: ketamine infusion (Drug)
zero/metadone
Methadone PCA
干预措施: Methadone PCA (Drug)
ketamine/methadone
Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery.
Methadone administered by a PCA system (dose 2 mg, lock-out 12min.).
干预措施: ketamine infusion (Drug)
ketamine/methadone
Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery.
Methadone administered by a PCA system (dose 2 mg, lock-out 12min.).
干预措施: Methadone PCA (Drug)
结局指标
主要结局
the Extent of Hyperalgesia Area Proximal to Surgical Wound
时间窗: 24 and 48 hours after surgery
Hyperalgesia is determined by stimulating with a won Fray hair N°16 along three lines at a right angle to the top, middle, and bottom sides of the surgical incision. Each line starts from the edge of the abdomen to the surgical incision. Stimulation continue from the edge toward the surgical incision until the patients reported a worsening in sensation The distance from the incision to where sensation change was measured. The mean of the three assessments was used as a measure of the extent of the hyperalgesia area.
次要结局
- Pain Intensity Measured by a Numeric Rating Scale (NRS)(24 and 48 hours after surgery)
- Opioid Consumption(48 hours)
研究者
Emiliano Tognoli
medical doctor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano