Continuous Lidocaine Infusion for Management of Perioperative Burn Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Narcotic Consumption (Measured in mg/kg Narcotic Consumption)
研究概览
简要总结
Thermal injury results in one of the most intense and prolonged forms of pain the body can experience. Opioid narcotics are the most powerful drugs for acute and chronic pain, and their use in the perioperative period has been the mainstay of treatment; although medication requirements in burn patients are often underestimated. More medication may not be the answer, as relatively large doses of short acting opioids in the operative theater are associated with greater postoperative opioid consumption and higher pain scores. Furthermore, extensive use of opioids has resulted in the development of by hyperalgesia and allodynia. Lidocaine is an amide local anesthetic that has analgesic, anti-hyperalgesic, antiarrhythmic, and anti-inflammatory properties. Over the past 25 years, systemic lidocaine has been used for perioperative pain management in a variety of surgical procedures. The design of this study will examine if lidocaine will reduce the pain scores and narcotic utilization in patients undergoing surgical procedures for burn injuries. The intervention group will receive a bolus dose of lidocaine followed by a continuous infusion over 24 hours. The control group will get an equal volume of saline. The investigators will compare pain scores, opioid use, and narcotic equivalents based on body weight and burn surface area (BSA) grafted.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Burn patient ≥ 18 years of age
- •Burn patient scheduled to go to OR for excision and/or grafting procedure
排除标准
- •Burn patient < 18 years of age
- •Intubated patient on sedation drip
- •Prolonged hypotension defined as Systolic Blood Pressure (SBP) < 90 mm/Hg for greater than 30 minutes in the pre-op area
- •Severe underlying cardiovascular disease (documented ejection fraction < 40%)
- •Documented conduction block, bradycardia or active congestive heart failure
- •Documented active gastritis or ulcers
- •Previous steroid medication history if documented adrenal insufficiency
- •Patient with documented liver disease
- •Patient with epilepsy or known seizure disorder
- •Pregnant Women
研究组 & 干预措施
Normal pain management
Normal saline (bolus followed by continuous infusion)
干预措施: Placebo (Other)
Lidocaine
Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)
干预措施: Lidocaine (Drug)
结局指标
主要结局
Narcotic Consumption (Measured in mg/kg Narcotic Consumption)
时间窗: 24-hours post surgery
The infusion was initiated at 1.5mg/kg for 30 minutes prior to surgery start, followed by a 2.0 mg/kg/hr infusion at the time of incision start. The rate was reduced to 1.5mg/kg/hr for the remainder of the 24 hour period. A standardized post-operative pain management strategy (morphine and oxycodone) was followed by clinical staff, based on a standardized pain scale rating tool. The difference in narcotic consumption and number of pain medication doses over the 72-hour post-operative period was compared using an unadjusted Wilcoxon rank sum test due to non-normal data distribution.
次要结局
未报告次要终点