PainPhase 4IMPALA ERASNCT07224711
The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
A Phase 4 study testing Lidocaine HCl 0.8% in D5W and Dextrose 5% in water in people with Pain and Post Operative Analgesia, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Post Operative Analgesia, Opioid Consumption, Postoperative
- What is being tested?
- Lidocaine HCl 0.8% in D5W and Dextrose 5% in water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,290 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2026to 31 Oct 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Miklos Kertai, MD, MMHC, PhD contact
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Danial Shams, MD, danial.shams@vumc.org
Gail Mayo, gail.mayo@vumc.org
About this study
Official title: The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery (IMPALA ERAS)
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).
- Being tested
- Lidocaine HCl 0.8% in D5W, Dextrose 5% in water
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HCl 0.8% in D5WDrug
1.5 mg /kg bolus of 0.8%lidocaine HCl in 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)
Dextrose 5% in waterDrug
Dextrose 5% in water (D5W) 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.
| Study group | Role | What they receive |
|---|---|---|
| LIdocaine | Active comparator | 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) Receives: Drug: Lidocaine HCl 0.8% in D5W |
| Placebo | Placebo comparator | Participants randomized to receive dextrose 5% in water (D5W) 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. Receives: Drug: Dextrose 5% in water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Case Mix Index-Adjusted Resource Length of Stay (CARLOS)
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.
Measured: Hospital admission to discharge (usually 4-7 days)
Total Inpatient opioid consumption
Total opioid consumption administered during the inpatient stay within the first 72 hours following initiation of the study medication. All opioid doses will be converted to oral morphine milligram equivalents (oMMEs) using standard conversion factors.
Measured: Start of study medication to 72 hours
Secondary outcomes (7)
Resource Length Of Stay (RLOS)
Duration a patient spends in a healthcare facility as a measure of resource use
Measured: Hospital admission to discharge (usually 4-7 days)
Case Mix Index
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.
Measured: Hospital admission to discharge (usually 4-7 days)
Total consumption of inpatient opioids
Total consumption of inpatient opioids measured in oral morphine milligram equivalents (oMME)
Measured: Day of surgery to hospital discharge (usually 4-7 days)
Pain Visual Analog Score
Pain measured with an 11 point visual analog score (0 to 10) where 0 represents no pain and 10 represents the worst pain imaginable.
Measured: 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
Incidence of surgical outcomes
Incidence of surgical outcomes such as bowel function, ileus, nausea, rapid response calls, surgical site infections, and Intensive Care Unit transfers
Measured: Surgery to 30 days after hospital discharge
Incidence of treatment side effects
Incidence of treatment side effects (double/blurry vision, tinnitus, sedation and events requiring early cessation of study treatment).
Measured: Anesthesia Induction to end of study treatment, less than or equal to 48 hours
Incidence of meeting early discharge milestones
Incidence of hospital discharge earlier than expected based on anticipated discharge day indicated at initial hospital booking
Measured: hospital discharge (usually 4-7 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start31 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2,290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danial Shams, Vanderbilt University Medical Center
- Investigators
- Danial Shams, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224711
- Sponsor's protocol ID
- 250617
- Acronym
- IMPALA ERAS
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rouleau GW, Smith AW, Parrish CG, Allen LJ, Jayaram JE, Ruble SR, Adkins CM, Eden S, Shotwell MS, Yaghmour ET, Statzer NJ, Wanderer JP, Henson CP, Shams D, Kertai MD, Investigators I; IMPALA Investigators. 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. BMJ Open. 2026 Sep 8;16(9):e120012. doi: 10.1136/bmjopen-2026-120012.
PubMed 42711072