The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Abdominal Surgery

Not Applicable

Not yet recruiting

• Conditions: Pain; Post Operative Analgesia; Opioid Consumption, Postoperative
• Interventions: Drug: Lidocaine HCl 0.8% in D5W; Drug: Sodium Chloride 0.9%

• Registration Number: NCT07224711
• Lead Sponsor: Vanderbilt University Medical Center

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 abdominal 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-21
• Study First Submitted QC: 2025-11-03
• Last Update Submitted: 2025-11-03
• Study First Posted: 2025-11-05
• Last Update Posted: 2025-11-05
• Study Start: 2026-06-01
• Primary Completion: 2028-05-30
• Study Completion: 2028-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2290

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIdocaine	Lidocaine HCl 0.8% in D5W	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	Sodium Chloride 0.9%	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.

Primary Outcome Measures

Name	Time	Method
Case Mix Index-Adjusted Resource Length of Stay (CARLOS)	Hospital admission to discharge (usually 4-7 days)	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.

Secondary Outcome Measures

Name	Time	Method
Resource Length Of Stay (RLOS)	Hospital admission to discharge (usually 4-7 days)	Duration a patient spends in a healthcare facility as a measure of resource use
Case Mix Index	Hospital admission to discharge (usually 4-7 days)	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.
Total consumption of inpatient opioids	Day of surgery to hospital discharge (usually 4-7 days)	Total consumption of inpatient opioids measured in oral morphine milligram equivalents (oMME)
Pain Visual Analog Score	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	Pain measured with an 11 point visual analog score (0 to 10) where 0 represents no pain and 10 represents the worst pain imaginable.
Incidence of surgical outcomes	Surgery to 30 days after hospital discharge	Incidence of surgical outcomes such as bowel function, ileus, nausea, rapid response calls, surgical site infections, and Intensive Care Unit transfers
Incidence of treatment side effects	Anesthesia Induction to end of study treatment, less than or equal to 48 hours	Incidence of treatment side effects (double/blurry vision, tinnitus, sedation and events requiring early cessation of study treatment).
Incidence of meeting early discharge milestones	hospital discharge (usually 4-7 days after surgery)	Incidence of hospital discharge earlier than expected based on anticipated discharge day indicated at initial hospital booking

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States