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NCT07224711
The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
Conditions: Pain, Post Operative Analgesia, Opioid Consumption, Postoperative
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 2290
Sponsor: Vanderbilt University Medical Center
Location: Vanderbilt University Medical Center Nashville Tennessee
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).
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)
Source: ClinicalTrials.gov (NCT07224711). StuddyBuddy aggregates publicly available trial information.