The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Abdominal Surgery (IMPALA ERAS)

Vanderbilt University Medical Center

Status and phase: Begins enrollment in 3 months; Phase 4

Conditions: Post Operative Analgesia; Opioid Consumption, Postoperative; Pain

Treatments: Drug: Lidocaine HCl 0.8% in D5W; Drug: Sodium Chloride 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT07224711

250617

Details and patient eligibility

About

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).

Enrollment: 2,290 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,290 participants in 2 patient groups, including a placebo group

LIdocaine

Active Comparator group

Description:

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)

Treatment:

Drug: Lidocaine HCl 0.8% in D5W

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Sodium Chloride 0.9%