A Comparison Between the Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy: A Prospective, Double-blind, Randomized, Placebo Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total opioid consumption
研究概览
简要总结
Open nephrectomy is one of the most common surgical procedures in urologic practice. Pain after surgery remains a significant clinical problem as it impairs recovery adversely and may lead to the transition to chronic pain. The open approach represents a major physical trauma including postoperative pain and discomfort in the convalescence period. Adequate control of postoperative pain facilitates earlier mobilization and rehabilitation. Patient-controlled analgesia (PCA) is effective to treat pain at rest, but seems to be inadequate for dynamic analgesia and may also elicit side effects that may delay hospital discharge. Preventing early and late postsurgical pain is an important challenge for anesthesiologists and surgeons.
Ketamine (N-Methyl-D-Aspartate receptor antagonist) and lidocaine (sodium channel blocker) are popular analgesic adjuvants for improving perioperative pain management. The investigators designed this double-blind, placebo controlled study to test and compare the preventive effects of perioperative intravenous ketamine and lidocaine on early and chronic pain after elective open nephrectomy.
The investigators propose a double-blind placebo-controlled study of patients undergoing elective open nephrectomy. All patients will receive normal "patient-controlled analgesia morphine" in addition to study drugs or placebo. Research will be conducted at Charles Nicolle teaching hospital.
详细描述
Participants will be randomized into one of three study groups: Group L: intravenous lidocaine: bolus of 1.5 mg/kg at induction of anesthesia followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively. Group K: Ketamine: bolus of 0.15 mg/kg followed by infusion of 0.1 mg/kg/h intraoperatively and for 24 h postoperatively. Control Group C: an equal volume of saline. The anesthetic technique will be standardized, and the postoperative assessments included pain scores, opioid consumption, recovery of bowel function and 6-minute walk distance (6-MWD) on the fourth postoperative morning. At 3 months, patients will be questioned for chronic postoperative pain using the Neuropathic Pain 4 questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Adult (>/=18)
- •male or female
- •Undergoing elective open nephrectomy
- •General anesthesia
- •Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.
排除标准
- •Pregnancy and breastfeeding
- •Cognitively impaired (by history)
- •Subject with a history of psychosis
- •Subject known to have significant hepatic disease
- •History of previous cardiac arrhythmia
- •Subject for whom opioids or ketamine are contraindicated
研究组 & 干预措施
Ketamine
Ketamine infused at 0.1 mg/kg/hour
干预措施: Ketamine (Drug)
Lidocaine
Lidocaine infused at 1 mg/kg/hour
干预措施: Lidocaine (Drug)
Placebo
An equal volume of saline
干预措施: Placebo (Drug)
结局指标
主要结局
Total opioid consumption
时间窗: 24 hours
the total amount of morphine consumed during follow up period
次要结局
- Postoperative nausea and vomiting using a Verbal Rating Scale(48 hours)
- Functional recovery assessed by 6 minute walk test (6MWT)(the fourth postoperative morning)
- chronic postoperative pain assessed by the Neuropathic Pain 4 questionnaire. (NP4)(At 3 months)
研究者
Ali JENDOUBI
MD, Assistant Professor
University Tunis El Manar