The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Abdominal Surgery

NCT ID: NCT07224711

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 2290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-01
• Study Completion Date: 2028-05-30

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 abdominal 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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Lidocaine HCl 0.8% in D5W

Intervention Type: 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)

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.

Group Type: PLACEBO_COMPARATOR

Sodium Chloride 0.9%

Intervention Type: 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.

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)

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age greater than or equal to 18
• American Society of Anesthesiologists (ASA) class II-IV
• Presenting for major elective, abdominal 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 women of childbearing potential are already tested as standard of care day of surgery and will be excluded from this study if found to be pregnant)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Danial Shams

Assistant Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danial Shams, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Central Contacts

Danial Shams, MD

Role: CONTACT

danial.shams@vumc.org

615-936-3198

Miklos Kertai, MD, MMHC, PhD

Role: CONTACT

miklos.kertai@vumc.org

Facility Contacts

Danial Shams, MD

Role: primary

danial.shams@vumc.org

Gail Mayo

Role: backup

gail.mayo@vumc.org

Other Identifiers

250617

Identifier Type: -

Identifier Source: org_study_id