Impact of PerioperAtive LidocAine Infusions on Enhanced Recovery After Noncardiac Surgery (IMPALA-ERAS) in an inpatient setting: rationale, design and protocol for a sequential, repeated crossover trial.

Gerald W Rouleau; Aden W Smith; Crystal G Parrish; Leslie J Allen; Jennifer E Jayaram; Sydney R Ruble; Claire M Adkins; Svetlana Eden; Matthew S Shotwell; Edward T Yaghmour; Nicholas J Statzer; Jonathan P Wanderer; Christopher Patrick Henson; Danial Shams; Miklos D Kertai; Impala Investigators; IMPALA Investigators

doi:10.1136/bmjopen-2026-120012

PubMed · 42711072

Impact of PerioperAtive LidocAine Infusions on Enhanced Recovery After Noncardiac Surgery (IMPALA-ERAS) in an inpatient setting: rationale, design and protocol for a sequential, repeated crossover trial.

Gerald W Rouleau·Aden W Smith·Crystal G Parrish·Leslie J Allen·Jennifer E Jayaram·Sydney R Ruble·Claire M Adkins·Svetlana Eden·Matthew S Shotwell·Edward T Yaghmour·Nicholas J Statzer·Jonathan P Wanderer·Christopher Patrick Henson·Danial Shams·Miklos D Kertai·Impala Investigators·IMPALA Investigators

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Abstract

INTRODUCTION: Multimodal analgesic strategies designed to minimise perioperative opioid exposure are fundamental components of enhanced recovery after surgery (ERAS) pathways. Despite widespread implementation of ERAS protocols, the optimal analgesic regimen remains undefined, as the individual contributions of specific agents to overall analgesic efficacy and opioid-sparing effects are not fully elucidated. Intravenous lidocaine, a widely utilised local anaesthetic, possesses both analgesic and anti-inflammatory properties and has been associated with improved gastrointestinal recovery. This study seeks to pragmatically evaluate the impact of incorporating perioperative intravenous lidocaine infusion into established ERAS pathways on postoperative functional recovery. METHODS AND ANALYSIS: The Impact of PerioperAtive LidocAine Infusions (IMPALA) on ERAS trial is a single-centre, pragmatic, cluster-randomised, double-blinded, placebo-controlled study. A total of 2290 patients undergoing elective colorectal surgery, emergency general surgery, urology, ventral hernia repair, surgical oncology or spine surgery will be randomly assigned to receive either intraoperative and postoperative intravenous lidocaine infusions (administered for up to 48 hours) or placebo as part of a standardised multimodal analgesic regimen integrated into established ERAS pathways. The primary outcome is case mix index-adjusted resource length of stay, defined as the time interval from surgical initiation to hospital discharge adjusted for case mix index. The primary outcome is total inpatient opioid consumption within the first 72 hours, reported in oral morphine milligram equivalents. Secondary outcomes include various in-hospital clinical endpoints derived from the electronic health record. ETHICS AND DISSEMINATION: This protocol and accompanying statistical analysis plan outline the study design, primary and secondary endpoints and analytic methodology. The IMPALA-ERAS trial has received ethical approval from the Vanderbilt University Institutional Review Board (IRB: 250617). The findings will be disseminated via peer-reviewed publications and presentations at national conferences. Results from this trial are expected to inform evidence-based practices regarding perioperative lidocaine infusion and its potential contributions to enhanced postoperative recovery in surgical patients. TRIAL REGISTRATION NUMBER: NCT07224711.

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Humans Lidocaine Double-Blind Method Anesthetics, Local Postoperative Pain Infusions, Intravenous Perioperative Care Enhanced Recovery After Surgery Cross-Over Studies Research Design Female Length of Stay Adult Adult anaesthesia Adult surgery PAIN MANAGEMENT Journal Article Randomized Controlled Trial Pragmatic Clinical Trial

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Gerald W Rouleau, Aden W Smith, Crystal G Parrish, Leslie J Allen, Jennifer E Jayaram, Sydney R Ruble, Claire M Adkins, Svetlana Eden, Matthew S Shotwell, Edward T Yaghmour, Nicholas J Statzer, Jonathan P Wanderer, Christopher Patrick Henson, Danial Shams, Miklos D Kertai, Impala Investigators, IMPALA Investigators. 2026-09-08. Impact of PerioperAtive LidocAine Infusions on Enhanced Recovery After Noncardiac Surgery (IMPALA-ERAS) in an inpatient setting: rationale, design and protocol for a sequential, repeated crossover trial.. https://doi.org/10.1136/bmjopen-2026-120012

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Adult subject Anesthetics, Local subject Cross-Over Studies subject Double-Blind Method subject Enhanced recovery after surgery subject Female subject Humans subject Infusions, Intravenous subject Journal Article subject Journal Article; Randomized Controlled Trial; Pragmatic Clinical Trial resource Length of Stay subject Lidocaine subject Pain Management subject Perioperative Care subject Postoperative Pain subject Randomized controlled trials study

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