The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
ASA class >IV
Emergent procedures
Allergy or any contraindication to lidocaine infusion
Patient refusal
Trial design
Design model
Parallel
Treatments tested in this trial
Lidocaine HCl 0.8% in D5W
Drug1.5 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%
DrugSodium 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 groups
2,290 Participants
are divided into 2 treatment groupsGroup A: LIdocaineActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Case Mix Index-Adjusted Resource Length of Stay (CARLOS)
The difference of CARLOS between the placebo and experimental groups in days. The Case Mix Index-Adjusted Resource Length of Stay is a hospital quality metric that standardizes average length of stay (LOS) to account for the complexity and severity of a hospital's patient population, represented by its Case Mix Index (CMI). A higher CMI indicates a more resource-intensive patient group, while a lower CMI reflects a simpler, less costly case mix.
Time frame
Hospital admission to discharge (usually 4-7 days)2
Total Inpatient opioid consumption
Total opioid consumption administered during the inpatient stay within the first 72 hours following initiation of the study medication. All opioid doses will be converted to oral morphine milligram equivalents (oMMEs) using standard conversion factors.
Time frame
Start of study medication to 72 hoursSecondary outcomes
1
Resource Length Of Stay (RLOS)
Duration a patient spends in a healthcare facility as a measure of resource use
Time frame
Hospital admission to discharge (usually 4-7 days)2
Case Mix Index
The difference of Case Mix Index (CMI) between the placebo and experimental groups in days. The Case Mix Index is a hospital quality metric that reflects the average clinical complexity and resource intensity of the patient population. A higher CMI indicates a more resource-intensive patient group, while a lower CMI reflects a simpler, less costly case mix.
Time frame
Hospital admission to discharge (usually 4-7 days)3
Total consumption of inpatient opioids
Total consumption of inpatient opioids measured in oral morphine milligram equivalents (oMME)
Time frame
Day of surgery to hospital discharge (usually 4-7 days)4
Pain Visual Analog Score
Pain measured with an 11 point visual analog score (0 to 10) where 0 represents no pain and 10 represents the worst pain imaginable.
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 dischargeSponsors and contacts
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Source ClinicalTrials.gov
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