The Effect of Perioperative Lidocaine on Postoperative Quality of Recovery in Patients Undergoing Spine Surgery: A Randomized, Double - Blinded, Placebo Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Quality of recovery
研究概览
简要总结
Acute postoperative pain is an unpleasant, unwanted sensory and emotional experience for the patient. The investigators seek to determine if the addition of systemic lidocaine can improve the quality of recovery after spine surgery and reduce the requirement for opiate therapy.
详细描述
Consented patients will be randomized to either saline group or lidocaine group. General anesthesia will be induced as it would normally be done in any patient undergoing spine surgery. Once the patient is positioned for the surgery bolus followed by the infusion of either the study drug or the placebo will be administered. The infusion will be stopped at the end of surgery and the patient will be transferred to the post anesthesia care unit. Post operative pain score will be evaluated for the first 24 hrs and also the amount of pain medications used will be recorded. At the end of 24 hours quality of recovery will be assessed using a qor-40 questionnaire.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18-80 yrs;
- •American Society of Anesthesiology Physical Status I, II or III; and
- •Patients undergoing thoracic or lumbosacral spine surgeries with or without instrumentation via the posterior approach with planned admission to the post anesthesia care unit after surgery-
排除标准
- •Allergy to any of the study medications or anesthetic agents used in the study;
- •American Society of Anesthesiology physical status IV;
- •Spine surgery with the expected duration of surgery being more than 4 hours as determined by the attending surgeon;
- •History of severe hepatic dysfunction with liver enzymes elevated to more than 3 times the normal or International normalized ratio of more than 2 and renal dysfunction with GFR less than 60 ml/min
- •History of previous spinal fusion or instrumentation;
- •Diagnosis of cancer of the spine;
- •History of surgery for abscess or osteomyelitis;
- •History of cardiac dysrhythmia or heart block;
- •History of chronic heroin or methadone use;
- •Preoperative use of any systemic corticosteroid;
- •History of seizure disorder; and
- •Patient inability to properly describe postoperative pain to investigators (dementia, delirium, psychiatric disorder).
研究组 & 干预措施
Lidocaine
Intravenous Lidocaine bolus of 1.5 mg/kg followed by infusion of 1.5 mg/kg/hr
干预措施: Lidocaine (Drug)
Placebo
Normal saline placebo infusion
干预措施: Placebo (normal saline) (Other)
结局指标
主要结局
Quality of recovery
时间窗: At 24 hours after surgery
次要结局
- Post operative pain(for the first 24 hours after surgery)
研究者
Suman Rajagopalan
Assistant Professor
Baylor College of Medicine