Effect of Perioperative Intravenous Lidocaine Administration or Epidural Anesthesia on Postoperative Outcomes in Complex Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Mean Pain Scores
研究概览
简要总结
The purpose of this study is determine if epidural anesthesia administered after surgery or lidocaine administered during surgery will decrease inflammation after spinal surgery and decrease the need for post operative pain medication compared to intravenous patient controlled analgesia. Participants undergoing spine surgery will be randomized into one of two groups;
- A.) General Anesthesia and postoperative Patient Controlled Analgesia and placebo IV infusion.
B.) General Anesthesia plus perioperative intravenous lidocaine infusion, and post operative Patient Controlled Analgesia.
详细描述
According to a survey of 1570 U.S neurosurgeons, in the United States about 527.000 spine surgeries were done in 1999. This represents close to 65% of the procedures performed by neurosurgeons. Furthermore, the number of hospitalizations related with spine surgery has significantly increased since 1970.
IV PCA is considered the standard of care for postoperative pain control after surgery. Intravenous opioids have significant side effects such as respiratory depression, postoperative nausea and vomiting and sedation. Furthermore, they cause delayed return of bowel function and ileus.
There is the possibility of surgically inserting a catheter into the epidural space at the end of surgery. In general epidural analgesia provides excellent pain relief after surgery and decreases opioid consumption significantly und thus opioid related postoperative complications. Furthermore epidural anesthesia affects the surgical stress response and might decrease inflammatory responses after surgery, thereby improving postoperative recovery and mobilization of the patients.
Intravenous local anesthetics have potent anti-inflammatory properties. They also decrease postoperative opioid consumption. Clinical studies have shown that perioperative local anesthetic administration significantly reduces the incidence of thrombosis and postoperative pain, shortens postoperative ileus and decreases duration of hospitalization.
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
- Triple (Participant, 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
- •18 to 75 years old at time of surgery - adult patients differ from pediatric patients in that adult spines are stiffer than pediatric patient.
- •Elective spine surgery
- •Two levels laminectomies or above with or without fusion or instrumentatioN
- •General anesthesia
- •Surgery performed at Cleveland Clinic with informed consent signed prior to sedation or anesthesia - consistent surgical team
排除标准
- •contraindication to lidocaine such as substantial hepatic impairment (ALT or AST more than twice normal)
- •renal impairment (serum creatinine >2 mg/dl),
- •seizure disorder requiring medication within 2 years
- •planned epidural anesthesia or analgesia
研究组 & 干预措施
Placebo
Perioperative placebo IV infusion besides the standard anesthesia care, including general anesthesia and postoperative patient controlled analgesia.
干预措施: placebo (Drug)
Lidocaine
Perioperative intravenous lidocaine infusion besides the standard anesthesia care, including general anesthesia plus and post operative patient controlled analgesia.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Mean Pain Scores
时间窗: From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier).
The pain score as measured by verbal response scores (scale ranging from 0 to 10 with 0=no pain; 10=worst pain) every 30 minutes during post anesthesia care unit stay, then per nursing floor protocol (roughly every 4-6 hours).
Opioid Medication Requirement, mg in IV Morphine Equivalent
时间窗: through postoperative day 2 (or discharge, if earlier)
Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents
次要结局
- Postoperative Nausea and Vomiting (PONV)(post op day one and two or till hospital discharge)
- Number of Participants With Any Major 30-day Post Operative Complications(30 days after surgery)
- Duration of Hospitalization(At discharge)
- 12-item Short Form Survey (SF-12) Physical Health Composite Score(90 days post operative)
研究者
Ehab Farag
Ehag Farag, MD
The Cleveland Clinic