What side effects are associated with this type of intervention?

Systemic lidocaine infusion, used for non-opioid pain management and anti-inflammatory effects, can cause several side effects. Common adverse events include dizziness, nausea, and a metallic taste. More serious side effects, although rare, can include central nervous system toxicity manifesting as seizures, and cardiovascular issues such as arrhythmias or hypotension. These side effects are generally transient and resolve upon discontinuation of the infusion.

What prior FDA approvals exist?

There is no specific mention of FDA approvals for systemic lidocaine infusion for non-opioid pain management and anti-inflammatory effects in the provided context. However, intravenous lidocaine is being studied for its potential to reduce postoperative opioid consumption and attenuate the systemic inflammatory response following major surgeries, such as spinal fusion for adolescent idiopathic scoliosis. This suggests that while systemic lidocaine infusion is under investigation, its use in clinical practice may still be limited and not yet broadly approved by the FDA for these specific indications.

What other types of research exist?

Promising alternatives to intravenous lidocaine for non-opioid pain management and anti-inflammatory effects include bisphosphonates, focused ultrasound, and multimodal analgesic strategies involving dexmedetomidine, gabapentin, ketamine, and NSAIDs. These options have shown efficacy in clinical trials for pain relief and inflammation reduction.

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IV Lidocaine for Post-Operative Pain in Pediatric Spinal Conditions (PEDS LIDO Trial)

Phase 4

Waitlist Available

Led By Scott Luhmann, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Parent/Guardian capable of providing informed consent for study participation

Ages between 12 and 18 years of age.

Must not have

Unable to obtain consent for the surgical intervention or study, or if mental capacity prohibits the ability to provide consent and complete patient-reported outcomes tools.

Past or current seizure disorders.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 weeks after surgery

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests if a medication can help manage pain after spinal surgery in teens with scoliosis. The goal is to reduce the need for stronger painkillers by using this medication, which numbs tissues and reduces pain. This medication has been studied for its potential to reduce pain and the need for stronger painkillers in various types of surgeries, including spine surgeries.

Who is the study for?

This trial is for adolescents aged 12-18 with idiopathic scoliosis needing spinal fusion surgery. They must have a guardian to consent and be able to complete surveys. Excluded are those outside the age range, with certain medical conditions like infections, cancer, seizure disorders or heart issues, involved in other trials, or unable to understand English without a translator.

What is being tested?

The study tests if IV lidocaine can manage post-surgery pain for spine fusion patients better than a placebo. It's randomized and triple-blind so neither doctors nor participants know who gets real medicine vs placebo. The focus is on reducing opioid use after surgery and speeding up recovery.

What are the potential side effects?

While not specified here, common side effects of IV lidocaine may include dizziness, sleepiness, changes in blood pressure or heart rate; rarely it can cause allergic reactions or seizures especially at high doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My parent or guardian can give consent for me to join the study.

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I am between 12 and 18 years old.

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I have scoliosis and need surgery to correct my spine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am able to understand and consent to the surgery or study on my own.

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I have had seizures in the past or have a seizure disorder.

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I am either younger than 12 or older than 18 years old.

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I have or had an irregular heartbeat or a mild heart block.

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I have been diagnosed with sepsis or an infection.

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I have been diagnosed with cancer, either at its original site or spread to other parts.

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My scoliosis treatment will involve surgery from the front.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 weeks after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 weeks after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Opioid consumption

Side effects data

From 2019 Phase 4 trial • 86 Patients • NCT03540030

Hospitalization for ileus

mesenteric artery stenosis

100%

80%

60%

40%

20%

Study treatment Arm

Non-Opioid Intervention

Observational

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Study GroupExperimental Treatment1 Intervention

will receive intravenous lidocaine during and after posterior spinal fusion for AIS

Group II: Control GroupPlacebo Group1 Intervention

will receive saline placebo during and after surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IV lidocaine

2016

Completed Phase 4

~90

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Systemic lidocaine infusion primarily works by blocking sodium channels, which inhibits nerve impulse conduction and reduces pain. It also has anti-inflammatory effects that help attenuate the body's inflammatory response to surgery or injury. These mechanisms are significant for patients as they can reduce the need for opioids, minimize opioid-related side effects, and promote faster recovery.

The effect of systemic lidocaine on post-operative opioid consumption in ambulatory surgical patients: a meta-analysis of randomized controlled trials.