Lidocaine Infusions for Postoperative Pain

(IMPALA ERAS Trial)

Overseen By Miklos Kertai, MD, MMHC, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Pregnancy, Allergy to lidocaine, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether lidocaine infusions, administered during and after surgery, can enhance recovery following major abdominal surgery. Researchers aim to determine if lidocaine reduces hospital stay duration, decreases the need for opioid painkillers, and improves recovery outcomes such as bowel function and infection rates. Participants will be randomly assigned to receive either lidocaine or a placebo (a substance with no treatment effect) through an IV. Suitable candidates have planned elective major abdominal surgery for conditions like colorectal or urology issues and can receive nerve blocks. As a Phase 4 trial, lidocaine is already FDA-approved and proven effective. This research seeks to understand its benefits for more patients, offering a chance to contribute to broader medical knowledge.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for lidocaine infusions?

Research has shown that lidocaine infusions can safely help manage pain after surgery. Several studies found that lidocaine reduces pain and decreases the need for opioids, which are strong painkillers. This can be especially useful after abdominal surgeries.

One review of 12 studies showed that lidocaine infusions not only reduced pain but also had a good safety record. Most patients did not experience serious side effects. Some common but mild side effects might include blurry vision or feeling sleepy, which usually do not require stopping the treatment.

Since this trial is in a later phase, lidocaine has been tested with positive safety results in earlier studies. This suggests the treatment is generally well-tolerated in people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using lidocaine infusions for postoperative pain because it offers a new approach compared to standard pain treatments like opioids. Unlike traditional methods that often rely on oral or injected painkillers, this treatment uses a continuous IV infusion of lidocaine, which can potentially offer more controlled and effective pain relief during and after surgery. This method may reduce the need for opioids, which are known for their potential for addiction and side effects. Additionally, lidocaine works by blocking nerve signals that transmit pain, offering a targeted mechanism for pain management.

What evidence suggests that lidocaine infusions might be an effective treatment for postoperative pain?

Research has shown that IV (intravenous) lidocaine can reduce pain after surgery. One study found it significantly lowered pain and the need for painkillers in the first 24 hours post-surgery. Another study demonstrated a reduction in moderate-to-severe pain for up to 48 hours after liver surgery. A review of several studies confirmed that lidocaine reduced pain soon after surgery and continued to do so 24 hours later. In this trial, participants will receive either lidocaine or a placebo to evaluate its effectiveness in managing postoperative pain. These findings suggest that lidocaine is a promising option for managing pain after major surgeries. ^{6 7 8 9 10}

Who Is on the Research Team?

Danial Shams, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for patients undergoing major abdominal surgery who can participate in the Enhanced Recovery After Surgery (ERAS) program. It's not clear what specific conditions exclude someone from this trial, as that information isn't provided.

Inclusion Criteria

I am 18 years old or older.

American Society of Anesthesiologists (ASA) class II-IV

Only my first surgery during the study period counts.

Exclusion Criteria

Pregnancy (all women of childbearing potential are already tested as standard of care day of surgery and will be excluded from this study if found to be pregnant)

ASA class >IV

Allergy or any contraindication to lidocaine infusion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Perioperative Treatment

Participants receive IV lidocaine or placebo during surgery and up to 48 hours postoperatively

Up to 48 hours

In-hospital stay

Hospital Stay

Participants remain in the hospital for recovery and monitoring of surgical outcomes and side effects

4-7 days

In-hospital stay

Follow-up

Participants are monitored for surgical outcomes and side effects up to 30 days after discharge

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine

Trial Overview The study tests if IV lidocaine helps patients recover faster after abdominal surgery compared to a placebo (saltwater solution). Patients are randomly chosen to receive either lidocaine or placebo and are monitored for hospital stay length, pain levels, opioid use, and surgical outcomes like infections or ICU transfers.

How Is the Trial Designed?

Group I: LIdocaine Active Control 1 Intervention

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)

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7901134/

Intravenous Lidocaine Infusion for the Management of Early ... The results of these reviews showed a remarkable reduction of pain and/or opioid requirements during the first 24 hours postoperatively.

2. associationofanaesthetists-publications.onlinelibrary.wiley.com associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.15270

The use of intravenous lidocaine for postoperative pain and ... Intravenous lidocaine is used widely for its effect on postoperative pain and recovery but it can be, and has been, fatal when used inappropriately and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0007091223001691

Pain Efficacy of prolonged intravenous lidocaine infusion ... Prolonged intravenous lidocaine infusion reduced the incidence of moderate-to-severe movement-evoked pain for 48 h after hepatectomy.

4. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(17)30243-X/fulltext

a systematic review with trial sequential analysis† Meta-analysis suggested that lidocaine reduced postoperative pain (visual analogue scale, 0 to 10 cm) at 1–4 h (MD −0.84, 95% CI −1.10 to −0.59) and at 24 h (MD ...

5. journals.lww.com journals.lww.com/10.1097/JS9.0000000000001942

Perioperative intravenous lidocaine infusion improves... Perioperative intravenous lidocaine infusion improves postoperative analgesia after hysterectomy: a systematic review and meta-analysis of ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818023001691

Effect and safety profile of topical lidocaine on post-surgical ... Topical lidocaine may lead to pain relief and is safe to use for patient with post-surgical pain, though its impact on quality of life is unclear.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9171272/

Lidocaine Infusion for the Management of Postoperative ... Together, these data suggest that lidocaine may decrease inflammatory-induced cognitive dysfunction, and possibly the development of ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03921567?cond=Analgesics&viewType=Table&rank=4

Intravenous Lidocaine for Perioperative and Postoperative ... Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540 ...

9. frontiersin.org frontiersin.org/journals/molecular-neuroscience/articles/10.3389/fnmol.2023.967917/full

A randomized controlled trial evaluating the effects of ... TAP block with 0.6% compound lidocaine hydrochloride injection attenuates postoperative pain, reduces opioid consumption, accelerates gastrointestinal function ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5370626/

The efficacy and safety of intravenous lidocaine for analgesia ... In total, 12 studies fulfilled the criteria. Lidocaine infusions were found to reduce pain scores and be opioid sparing in abdominal and urological surgery, in ...