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
Qualifiers
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
Treatments tested in this trial
- Lidocaine HCl 0.8% in D5W
- Sodium Chloride 0.9%
Treatment groups
2,290 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov