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Not yet recruiting NCT07224711

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

Phase IV Interventional Pain Post Operative Analgesia Opioid Consumption, Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lidocaine HCl 0.8% in D5W, Sodium Chloride 0.9%.
Who it may be relevant to
Registry conditions: Pain, Post Operative Analgesia, Opioid Consumption, Postoperative. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • Resource Length Of Stay (RLOS) [Time frame: Hospital admission to discharge (usually 4-7 days)]
  • Case Mix Index [Time frame: Hospital admission to discharge (usually 4-7 days)]
  • Total consumption of inpatient opioids [Time frame: Day of surgery to hospital discharge (usually 4-7 days)]
  • Pain Visual Analog Score [Time frame: 0 (first pain score in Post Anesthesia Care Unit (PACU) or Intensive Care Unit(ICU)), 4, 8, 12, 24, 48, 72 hours after PACU/ICU admission and at hospital discharge]
  • Incidence of surgical outcomes [Time frame: Surgery to 30 days after hospital discharge]
  • Incidence of treatment side effects [Time frame: Anesthesia Induction to end of study treatment, less than or equal to 48 hours]
  • Incidence of meeting early discharge milestones [Time frame: hospital discharge (usually 4-7 days after surgery)]

Eligibility criteria

Inclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT07224711 · 250617

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗