Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIdocaine | Active Comparator | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Hospital admission to discharge (usually 4-7 days) |
| 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. | Start of study medication to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Resource Length Of Stay (RLOS) | Duration a patient spends in a healthcare facility as a measure of resource use | Hospital admission to discharge (usually 4-7 days) |
| 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. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danial Shams, MD | Contact | 615-936-3198 | danial.shams@vumc.org | |
| Miklos Kertai, MD, MMHC, PhD | Contact | miklos.kertai@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Danial Shams, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| Hospital admission to discharge (usually 4-7 days) |
| Total consumption of inpatient opioids | Total consumption of inpatient opioids measured in oral morphine milligram equivalents (oMME) | Day of surgery to hospital discharge (usually 4-7 days) |
| 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. | 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 | Incidence of surgical outcomes such as bowel function, ileus, nausea, rapid response calls, surgical site infections, and Intensive Care Unit transfers | Surgery to 30 days after hospital discharge |
| Incidence of treatment side effects | Incidence of treatment side effects (double/blurry vision, tinnitus, sedation and events requiring early cessation of study treatment). | Anesthesia Induction to end of study treatment, less than or equal to 48 hours |
| Incidence of meeting early discharge milestones | Incidence of hospital discharge earlier than expected based on anticipated discharge day indicated at initial hospital booking | hospital discharge (usually 4-7 days after surgery) |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided