NCT07224711|Not Yet RecruitingPhase 4DMCFDA Drug
The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
IMPALA ERAS
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Sponsor study identifier
interventional
2,290
1 country
1
Study Start
October 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2025
Actual (reported)November 5, 2025
Actual (reported)October 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Case Mix Index-Adjusted Resource Length of Stay (CARLOS)
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.
Hospital admission to discharge (usually 4-7 days)
Total Inpatient opioid consumption
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.
Start of study medication to 72 hours
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
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)
Participants randomized to receive dextrose 5% in water (D5W) 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.
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)
Dextrose 5% in water (D5W) 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.
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Rouleau GW, Smith AW, Parrish CG, Allen LJ, Jayaram JE, Ruble SR, Adkins CM, Eden S, Shotwell MS, Yaghmour ET, Statzer NJ, Wanderer JP, Henson CP, Shams D, Kertai MD, Investigators I; IMPALA Investigators. Impact of PerioperAtive LidocAine Infusions on Enhanced Recovery After Noncardiac Surgery (IMPALA-ERAS) in an inpatient setting: rationale, design and protocol for a sequential, repeated crossover trial. BMJ Open. 2026 Sep 8;16(9):e120012. doi: 10.1136/bmjopen-2026-120012.
Danial Shams, MD
Vanderbilt University Medical Center
First Submitted
October 21, 2025
First Posted
November 5, 2025
Study Start
October 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
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October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 15, 2026
Record last verified: 2026-10
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