The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery

NCT07224711 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 250617
• Study Type: interventional
• Target: 2,290
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pain; Post Operative Analgesia; Opioid Consumption, Postoperative

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (2)

LIdocaine

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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%

Interventions

Lidocaine HCl 0.8% in D5W DRUG

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)

LIdocaine

Sodium Chloride 0.9% DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Danial Shams, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danial Shams, MD

CONTACT

615-936-3198; danial.shams@vumc.org

Miklos Kertai, MD, MMHC, PhD

CONTACT

miklos.kertai@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: November 5, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)