Opioid Consumption, Postoperative, Pain, Post Operative Analgesia
Conditions
Brief 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).
Interventions
DRUGLidocaine 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)
DRUGSodium 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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Case Mix Index-Adjusted Resource Length of Stay (CARLOS) | Hospital admission to discharge (usually 4-7 days) | 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. |
| Total Inpatient opioid consumption | Start of study medication to 72 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resource Length Of Stay (RLOS) | Hospital admission to discharge (usually 4-7 days) | Duration a patient spends in a healthcare facility as a measure of resource use |
| Case Mix Index | Hospital admission to discharge (usually 4-7 days) | 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. |
| Total consumption of inpatient opioids | Day of surgery to hospital discharge (usually 4-7 days) | Total consumption of inpatient opioids measured in oral morphine milligram equivalents (oMME) |
| Pain Visual Analog Score | 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 | Pain measured with an 11 point visual analog score (0 to 10) where 0 represents no pain and 10 represents the worst pain imaginable. |
| Incidence of surgical outcomes | Surgery to 30 days after hospital discharge | Incidence of surgical outcomes such as bowel function, ileus, nausea, rapid response calls, surgical site infections, and Intensive Care Unit transfers |
| Incidence of treatment side effects | Anesthesia Induction to end of study treatment, less than or equal to 48 hours | Incidence of treatment side effects (double/blurry vision, tinnitus, sedation and events requiring early cessation of study treatment). |
| Incidence of meeting early discharge milestones | hospital discharge (usually 4-7 days after surgery) | Incidence of hospital discharge earlier than expected based on anticipated discharge day indicated at initial hospital booking |
Countries
United States
Contacts
CONTACTDanial Shams, MD
CONTACTMiklos Kertai, MD, MMHC, PhD
PRINCIPAL_INVESTIGATORDanial Shams, MD
Vanderbilt University Medical Center
Outcome results
None listed