NCT07224711 The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
| NCT ID | NCT07224711 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,290 participants |
| Start Date | 2026-10-26 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,290 participants in total. It began in 2026-10-26 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion criteria: * Age greater than or equal to 18 * American Society of Anesthesiologists (ASA) class I-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)
Contact & Investigator
Danial Shams, MD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT07224711 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07224711 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07224711 currently recruiting?
Yes, NCT07224711 is actively recruiting participants. Contact the research team at danial.shams@vumc.org for enrollment information.
Where is the NCT07224711 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT07224711 clinical trial?
NCT07224711 is sponsored by Vanderbilt University Medical Center. The principal investigator is Danial Shams, MD at Vanderbilt University Medical Center. The trial plans to enroll 2,290 participants.