Effect of Intravenous Lidocaine Infusion on Long Term Postoperative Pain After Spinal Fusion Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- numerical rating scale (NRS), pain score.
研究概览
简要总结
Spinal fusion is a painful surgery, and control of postoperative pain is difficult. Several studies have indicated that appropriate pain treatment protocols reduce postoperative morbidity, improve the results of the surgery, and decrease hospital costs
详细描述
Forty four patients were randomly allocated into two groups of equal size to receive either lidocaine infusion (Lidocaine group) or 0.9% sodium chloride infusion (Control group).
Randomization: was performed using Lidocaine group and Control group registers, which was placed in sealed envelopes prior to study initiation and opened prior to anesthesia by a physician who prepared the intravenous solution and identified it with the patient number, according to the envelope drawn. The solution was handed to another physician, blind to the prepared solutions' content, who was responsible for the anesthesia. The solution volume was equal. The responsible investigator was remained blind to the chosen group until the end of the study.
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 (Care Provider, Investigator)
盲法说明
Double Blind
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years American Society of Anesthesiologists 1-3 status Patients undergoing spinal fusion or fixation
排除标准
- •Previous spinal fusion surgery.
- •Morbid obesity (BMI > 40)
- •Diagnosis of spinal metastatic cancer
- •Allergy to an amide local anesthetic or morphine sulfate
- •History of renal dysfunction, liver dysfunction or congestive heart failure
- •History of substance abuse disorder.
- •Chronic opioid use.
研究组 & 干预措施
Lidocaine group
Patients will receive lidocaine infusion.
干预措施: Lidocaine (Drug)
Control group
Patients will receive 0.9% Sodium-chloride infusion infusion
干预措施: 0.9% Sodium-chloride (Drug)
结局指标
主要结局
numerical rating scale (NRS), pain score.
时间窗: Postoperative 3 months
Postoperative numerical rating scale (NRS), pain score.
次要结局
- opioid consumption.(Postoperative 24 h)
- Serum cortisol.(Postoperative 24 h)
研究者
Abdelrady S Ibrahim, MD
Assistant professor of anesthesia and ICU
Assiut University