The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery (IMPALA ERAS)

The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery (IMPALA ERAS)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Post Operative Analgesia; Opioid Consumption, Postoperative
• Intervention / Treatment: Drug: Lidocaine HCl 0.8% in D5W; Drug: Sodium Chloride 0.9%

• Study Type: Interventional
• Enrollment (Estimated): 2290
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Danial Shams, MD; Phone Number: 615-936-3198; Email: danial.shams@vumc.org
• Study Contact Backup: Name: Miklos Kertai, MD, MMHC, PhD; Email: miklos.kertai@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
      • Contact: Danial Shams, MD; Email: danial.shams@vumc.org
      • Contact: Gail Mayo; Email: gail.mayo@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Drug: Lidocaine 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)
Placebo Comparator: 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.	Drug: Sodium 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resource Length Of Stay (RLOS)	Duration a patient spends in a healthcare facility as a measure of resource use	Hospital admission to discharge (usually 4-7 days)
Case Mix Index	The difference of Case Mix Index (CMI) between the placebo and experimental groups in days. The Case Mix Index is a hospital quality metric that reflects the average clinical complexity and resource intensity of the patient population. 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 consumption of inpatient opioids	Total consumption of inpatient opioids measured in oral morphine milligram equivalents (oMME)	Day of surgery to hospital discharge (usually 4-7 days)
Pain Visual Analog Score	Pain measured with an 11 point visual analog score (0 to 10) where 0 represents no pain and 10 represents the worst pain imaginable.	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	Incidence of surgical outcomes such as bowel function, ileus, nausea, rapid response calls, surgical site infections, and Intensive Care Unit transfers	Surgery to 30 days after hospital discharge
Incidence of treatment side effects	Incidence of treatment side effects (double/blurry vision, tinnitus, sedation and events requiring early cessation of study treatment).	Anesthesia Induction to end of study treatment, less than or equal to 48 hours
Incidence of meeting early discharge milestones	Incidence of hospital discharge earlier than expected based on anticipated discharge day indicated at initial hospital booking	hospital discharge (usually 4-7 days after surgery)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Danial Shams, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: October 21, 2025
• First Submitted That Met QC Criteria: November 3, 2025
• First Posted (Actual): November 5, 2025

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Lidocaine; Sodium Chloride
• Other Study ID Numbers: 250617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes