The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery (IMPALA ERAS)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 2,290
- 试验地点
- 1
- 主要终点
- Case Mix Index-Adjusted Resource Length of Stay (CARLOS)
研究概览
简要总结
The goal of this single-center, pragmatic, randomized, blinded, placebo-controlled trial is to evaluate the impact of intravenous (IV) lidocaine within the existing Enhanced Recovery After Surgery (ERAS)program on outcomes in patients after major non-cardiac surgery. The main questions the trial aims to answer are:
The primary hypothesis is that utilization of IV lidocaine as part of a perioperative multimodal pain regimen will result in a reduction in hospital Case Mix Index-Adjusted Resource Length of Stay (CARLOS).
The secondary hypotheses are that lidocaine infusion will result in a reduction in total inpatient opioid consumption (oral morphine milligram equivalents, oMMEs) and pain scores, and improved surgical outcomes (including return of bowel function, ileus, nausea, rapid responses called, surgical site infections, and ICU transfers), while also having minimal incidence of side effects (including double/blurry vision, tinnitus, sedation, and adverse events requiring early cessation).
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, Care Provider, Investigator)
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
- •Age greater than or equal to 18
- •American Society of Anesthesiologists (ASA) class II-IV
- •Presenting for major elective, non-cardiac surgery on the colorectal, emergency general surgery, urology, ventral hernia, surgical oncology, or spine services on a weekday
- •First surgery in the study period (if a patient has multiple surgeries, only the first will be included)
排除标准
- •ASA class >IV
- •Emergent procedures
- •Allergy or any contraindication to lidocaine infusion
- •Patient refusal
- •Unable to receive or refusal to receive a regional nerve block
- •Patients who receive an epidural due to standard of care
- •Direct transfer from operating room to ICU with endotracheal tube in place
- •Treating team determines patient ineligible prior to study drug administration
- •Same day surgery
- •Pregnancy (all female patient of child-bearing age will undergo a pregnancy test the day of surgery)
研究组 & 干预措施
LIdocaine
Participants randomized to receive 1.5 mg /kg bolus of 0.8% lidocaine Hydrochoride (HCL) in dextrose 5% in water (D5W) via IV with induction, prior to infusion started. The IV bolus will be followed by continuous IV infusion of 2 mg/minute of 0.8% lidocaine HCl in D5W intraoperatively with weight-based gradated dosing postoperatively (1-2 mg/minute)
干预措施: Lidocaine HCl 0.8% in D5W (Drug)
Placebo
Participants randomized to receive sodium chloride 0.9% via IV with induction, prior to infusion started. The IV bolus will be equivalent in volume to the lidocaine arm. The bolus will be followed by continuous IV infusion intraoperatively and then up to 48 hours. The continuous IV infusion will be equivalent in volume and rate to the lidocaine arm.
干预措施: Sodium Chloride 0.9% (Drug)
结局指标
主要结局
Case Mix Index-Adjusted Resource Length of Stay (CARLOS)
时间窗: Hospital admission to discharge (usually 4-7 days)
The difference of CARLOS between the placebo and experimental groups in days. The Case Mix Index-Adjusted Resource Length of Stay is a hospital quality metric that standardizes average length of stay (LOS) to account for the complexity and severity of a hospital's patient population, represented by its Case Mix Index (CMI). A higher CMI indicates a more resource-intensive patient group, while a lower CMI reflects a simpler, less costly case mix.
Total Inpatient opioid consumption
时间窗: Start of study medication to 72 hours
Total opioid consumption administered during the inpatient stay within the first 72 hours following initiation of the study medication. All opioid doses will be converted to oral morphine milligram equivalents (oMMEs) using standard conversion factors.
次要结局
- Resource Length Of Stay (RLOS)(Hospital admission to discharge (usually 4-7 days))
- Case Mix Index(Hospital admission to discharge (usually 4-7 days))
- Total consumption of inpatient opioids(Day of surgery to hospital discharge (usually 4-7 days))
- Pain Visual Analog Score(0 (first pain score in Post Anesthesia Care Unit (PACU) or Intensive Care Unit(ICU)), 4, 8, 12, 24, 48, 72 hours after PACU/ICU admission and at hospital discharge)
- Incidence of surgical outcomes(Surgery to 30 days after hospital discharge)
- Incidence of treatment side effects(Anesthesia Induction to end of study treatment, less than or equal to 48 hours)
- Incidence of meeting early discharge milestones(hospital discharge (usually 4-7 days after surgery))
研究者
Danial Shams
Assistant Professor of Anesthesiology
Vanderbilt University Medical Center