The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery (IMPALA ERAS)
Vanderbilt University Medical Center
Summary
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: * 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) Exclusion criteria: * 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 * Pati…
Interventions
- DrugLidocaine HCl 0.8% in D5W
1.5 mg /kg bolus of 0.8%lidocaine HCl in 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)
- DrugSodium Chloride 0.9%
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.
Location
- Vanderbilt University Medical CenterNashville, Tennessee