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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07224711
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Opioid Consumption, Postoperative
  • Pain
  • Post Operative Analgesia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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)
  • 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.

Study Details

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).

Key Dates

Start date
Jul 1, 2026
Status verified
Mar 2026
Primary completion
May 30, 2028
Completion
May 30, 2028

Study Design

Enrollment
2,290 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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 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.

Primary Outcome Measure

Case Mix Index-Adjusted Resource Length of Stay (CARLOS) [ Time Frame: Hospital admission to discharge (usually 4-7 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Danial Shams, MD
[email protected]
Gail Mayo
[email protected]

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