Lidocaine and Ketamine in Abdominal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Pain scores
研究概览
简要总结
The investigators propose to test the hypothesis that perioperative infusions of lidocaine and/or ketamine reduce opioid consumption and pain scores in adults recovering from elective inpatient abdominal surgery.
详细描述
The investigators propose a prospective, randomized, double-blind, placebo-controlled clinical trial (RCT) with a factorial design. Adults 18 to 80 years old having elective inpatient open or laparoscopic abdominal surgery with general anesthesia lasting 2 hours or longer will be included in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Pharmacy-prepared medications.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 to 80 years old
- •Elective inpatient open or laparoscopic abdominal surgery
- •General anesthesia lasting 2 hours or longer.
排除标准
- •Planned postoperative mechanical ventilation
- •Planned regional anesthesia/analgesia
- •Perioperative gabapentin, magnesium, or nitrous oxide use
- •Pregnancy or breastfeeding
- •Morbid obesity (BMI ≥ 35 kg/m2)
- •American Society of Anesthesiologists (ASA) physical status IV-V
- •Allergy to study medications
- •Contraindication to lidocaine (severe cardiac arrhythmia)
- •Contraindication to ketamine (psychiatric disorder, substance abuse, uncontrolled hypertension, pulmonary hypertension, increased intracranial or intraocular pressure, use of monoamine oxidase inhibitors)
- •Chronic preoperative opioid use (≥ 90 morphine mg equivalents per day for > 3 months)
- •Significant preoperative hepatic dysfunction (alanine aminotransferase or aspartate aminotransferase levels > 5 times normal) or planned liver transplantation
- •Preoperative cardiac failure (left ventricular ejection fraction ≤ 40%)
- •Unable to communicate or comprehend study instructions
研究组 & 干预措施
Lidocaine and placebo
Lidocaine and placebo
干预措施: Lidocaine (Drug)
Ketamine and placebo
Ketamine and placebo
干预措施: Ketamine (Drug)
Lidocaine and ketamine
Lidocaine and ketamine
干预措施: Lidocaine and ketamine (Drug)
Placebo and placebo
Placebo and placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pain scores
时间窗: First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).
Pain scores based on the visual analog scale and Brief Pain Inventory. Ranges from 0 to 10, with 0 being no pain and 10 being the worst imaginable pain. The intervention will be deemed effective if both outcomes are non-inferior, and at least one is superior, to the control group.
Total opioid consumption
时间窗: First postoperative 48 hours
Total opioid consumption in oral morphine equivalents (mg) from the time of transfer to PACU through to the second postoperative morning. The intervention will be deemed effective if both outcomes are non-inferior, and at least one is superior, to the control group.
次要结局
- Quality of recovery (QoR-15) score(First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).)
- Overall benefit of analgesia score (OBAS)(First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).)