Recruiting
Phase 4

Lidocaine

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07224711

Conditions

Pain

Post Operative Analgesia

Opioid Consumption, Postoperative

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lidocaine HCl 0.8% in D5W

Dextrose 5% in water

Study Details

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

Study ID

NCT07224711

Start date

Oct 26, 2026

Status verified date

Oct, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Age greater than or equal to 18
  • American Society of Anesthesiologists (ASA) class I-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 Design

Enrollment

2290 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

placebo comparator: Placebo

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.

Interventions

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)

Dextrose 5% in water

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.

Primary outcome measure

  • Case Mix Index-Adjusted Resource Length of Stay (CARLOS) [ Time Frame: Hospital admission to discharge (usually 4-7 days) ]
  • Total Inpatient opioid consumption [ Time Frame: Start of study medication to 72 hours ]

Central Contacts and Locations

Central contacts

Danial Shams, MD

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

Miklos Kertai, MD, MMHC, PhD

miklos.kertai@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Danial Shams, MD

danial.shams@vumc.org

Gail Mayo

gail.mayo@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.