NCT07224711

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,290 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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)
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.

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-05-30
• Completion: 2028-05-30
• First posted: 2025-11-05
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study