The Effect of Perioperative Intravenous Lidocaine Infusion on Opioid Consumption After Lumbar Spine Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Total morphine equivalent consumed at 24 hours after surgery
研究概览
简要总结
The purpose of this study is to determine whether an infusion of lidocaine during surgery can reduce the need for postoperative opioid pain medication use in patients undergoing lumbar spine surgery.
Participants will be recruited by spine surgeons from their pool of patients who are presenting for surgery at University of Vermont Medical Center. If they agree to participate, patients will be assigned at random to receive either an infusion of lidocaine during surgery, or an infusion of saline with 5% dextrose. Subjects will also be asked to complete a 15-item questionnaire that asks about health, quality of life, and level of pain, at three timepoints. Patients will also be asked to rate their level of pain at multiple timepoints after surgery, and we will collect the additionally data from patients' medical records.
详细描述
Lidocaine has analgesic and anti-inflammatory effects. It has been shown to reduce early postoperative pain and nausea. Additionally, lidocaine has been shown to have positive effects in the recovery of bowel function, with a reduction in time to first flatus, first bowel sounds, first bowel movement, and is associated with a reduction of ileus. Because of these facts, lidocaine infusion has become part of enhanced recovery pathways after bowel surgery at our institution and others.
There are few trials examining the use of lidocaine for orthopedic procedures and many of these studies have contradictory adults. An article by Martin et al. found no benefit in pain or recovery after total hip arthroplasty. By contrast, Farag and colleagues found that lidocaine significantly improves postoperative pain after major spine surgery. Additionally, quality of life scores at one and three months after surgery were significantly higher in the lidocaine group. When our Spine Surgery Analgesic Protocol for major spine surgery at University of Vermont Medical Center was revised in 2015, a lidocaine infusion was added to the protocol.
Studies for lidocaine use in minor lumbar surgery are scant. In one study of 50 patients in Korea, patient pain scores and fentanyl consumption were significantly lower in the lidocaine infusion group (1.5 mg/kg bolus plus 2 mg/kg/hr infusion) at 2, 4, 8, 12 and 24 hours after surgery. Of note, the Cleveland Clinic Outcomes group is currently enrolling 440 patients in a study in which half will receive lidocaine and ketamine infusions.
A reduction in opioid use may lead to the potential reduction of opioid-related side effects, such as nausea, constipation, and hyperalgesia, as well as more serious consequences such as respiratory depression and abuse. There is also the possibility of a length of stay reduction which has potential financial benefits.
This is a randomized, controlled, double-blind study involving patients undergoing one- or two-level posterior lumbar instrumented spinal fusion with or without decompression.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing one- or two-level posterior lumbar fusion with or without decompression at University of Vermont Medical Center
- •18-75 years of age
- •Signed consent form
排除标准
- •Allergy to lidocaine
- •Contraindication to lidocaine, such as substantial hepatic impairment (alanine aminotransferase or aspartate transaminase more than twice normal), renal impairment (serum creatinine >2 mg/dl)
- •Seizures or a history of seizure disorder
- •Congestive heart failure
- •Arrythmias
- •Chronic opioid use >45 mg morphine equivalent per day
- •Trauma patients
- •Inter-body fusions
- •Severe psychiatric comorbidities
- •Planned epidural anesthesia or analgesia
研究组 & 干预措施
Intravenous Lidocaine Infusion
Patients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min.
干预措施: Intravenous Lidocaine Infusion (Drug)
Placebo Infusion
Patients will be randomly assigned to receive a 1mg/kg bolus of water with 5% dextrose and an intraoperative infusion of 2mg/min. of water with 5% dextrose.
干预措施: Placebo Infusion (Drug)
结局指标
主要结局
Total morphine equivalent consumed at 24 hours after surgery
时间窗: 24 hours postoperatively
Subjects will receive a patient-controlled analgesia pump for the first 24 hours after surgery. Total morphine equivalent will be calculated according to the Centers for Disease Control and Prevention conversion factor for calculating morphine milligram equivalents.
次要结局
- Pain score 4 hours post-operation(4 hours postoperatively)
- Pain score 10 hours post-operation(10 hours postoperatively)
- Length of Stay(During hospitalization, approximately 5 days)
- Pain score 48 hours post-operation(48 hours postoperatively)
- Total morphine equivalent consumed at 48 hours after surgery(48 hours postoperatively)
- Pain score 24 hours post-operation(24 hours postoperatively)
- Quality of Recovery Score 48 hours post-operation(48 hours postoperatively)
- Quality of Recovery Score 36 hours post-operation(36 hours postoperatively)
- Incidence of nausea(During hospitalization, approximately 5 days)
- Time to first flatus(96 hours postoperatively)
- Time to first bowel movement(96 hours postoperatively)
研究者
Tim Dominick
Anesthesiologist
University of Vermont Medical Center