Lidocaine for Spinal Diseases

Overseen By Lauren K Buhl, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Pregnancy, Incarceration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 1

Duration: Up to 24 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how lidocaine, a common numbing medication, affects nerve monitoring during spine surgery. The goal is to determine if lidocaine can enhance the safety and effectiveness of spine surgeries by improving nerve monitoring. Participants will receive either a lidocaine infusion or a saline solution (a harmless saltwater mix) to compare the effects. Individuals undergoing specific types of spine surgery with nerve monitoring may be suitable for this study. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

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?

Previous studies have shown that patients undergoing spine surgery generally tolerate intravenous lidocaine well. Research indicates that lidocaine can help manage post-surgical pain and may reduce the risk of delirium, a state of confusion. However, some risks exist. For instance, using lidocaine in spinal procedures with a single injection carries a rare risk of nerve problems, but this method will not be used in this trial. Overall, evidence suggests that lidocaine is safe for most people when administered as an infusion during surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for spinal diseases, which often rely on medications like NSAIDs, corticosteroids, or opioids, lidocaine is being explored for its unique mechanism as a local anesthetic that can be delivered via infusion. Researchers are excited because lidocaine works by blocking nerve signals directly, potentially offering more targeted pain relief with fewer systemic side effects. Additionally, lidocaine infusion might provide faster relief compared to oral medications, which need time to circulate through the body. This could make lidocaine a game-changer for patients looking for quicker and possibly safer pain management options.

What is the effectiveness track record for lidocaine in spinal surgery?

Research shows that lidocaine can help reduce pain for people undergoing spine surgery. Studies have found that it lowers pain levels and reduces the need for opioid pain medication post-surgery. In this trial, some participants will receive a lidocaine infusion, which previous studies have shown significantly lowers pain at various times after surgery. Another study found that it improved patients' quality of life by easing pain and related issues like depression. Overall, lidocaine is considered a helpful option for managing pain in spine surgery patients. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients having elective cervical or thoracolumbar spine surgery with special nerve function monitoring. Participants must understand English to give consent and cannot be pregnant, allergic to lidocaine, planned for breathing tube after surgery, or incarcerated.

Inclusion Criteria

I am having spine surgery with nerve function monitoring.

Exclusion Criteria

I cannot give informed consent in English.

Pregnancy (based on patient report or a positive test on the day of surgery)

Contraindication to lidocaine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spine surgery with intraoperative neurophysiologic monitoring, receiving either lidocaine or normal saline infusion

Up to 24 hours

1 visit (in-person)

Follow-up

Participants are monitored for post-operative outcomes including VAS pain scores and opioid consumption

3 days

Post-operative monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine

Trial Overview

The study is testing the effects of a drug called Lidocaine when infused during spine surgery. It's compared against a saltwater solution (normal saline). The goal is to see how Lidocaine affects the thresholds of motor evoked potentials - signals related to muscle movements.

How Is the Trial Designed?

Group I: Lidocaine Infusion (Active) Active Control 1 Intervention

Lidocaine infusion

Group II: Normal Saline Infusion (Sham) Placebo Group 1 Intervention

Normal saline infusion

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Published Research Related to This Trial

Lidocaine, when used for spinal anesthesia, has been associated with a higher risk of neurotoxicity compared to other local anesthetics like bupivacaine and tetracaine, with a risk of persistent lumbosacral neuropathy occurring in about 1 in 1300 procedures for single injections and up to 1 in 200 for continuous spinal anesthesia.

Lidocaine is also linked to transient neurologic symptoms, which can cause significant pain in the buttocks or legs after anesthesia, affecting up to one third of patients, although this pain usually resolves within a week.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential neurotoxicity of spinal anesthesia with lidocaine. Johnson, ME.[2022]

In a study involving young male Sprague-Dawley rats, intraparenchymal injection of 0.5% lidocaine into the cervical spinal cord did not cause neuronal damage or inflammation, suggesting it may have a safe profile for local treatment.

The 0.5% lidocaine concentration is proposed to have potential anti-inflammatory effects following spinal cord injury, making it a promising candidate for treating neurodegenerative disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an Intraparenchymal Injection of Lidocaine in the Rat Cervical Spinal Cord. Sisti, MS., Zanuzzi, CN., Nishida, F., et al.[2018]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34196720/

Perioperative Intravenous Lidocaine Infusion for Post- ...

Intravenous lidocaine administration was associated with significantly reduced visual analogue pain scores at two MD= -1.13, four-six MD =-0.79 ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1094715922009552

PO005 / #279 EFFECTIVENESS OF LIDOCAINE ...

Our study, although small, clearly shows improved pain scores in most patients and consequently improved symptoms of depression and improved quality of life.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03624985

The Effect of Perioperative Intravenous Lidocaine Infusion ...

The purpose of this study is to determine whether an infusion of lidocaine during surgery can reduce the need for postoperative opioid pain medication use ...

4.

journals.lww.com

journals.lww.com/md-journal/fulltext/2020/11250/effect_of_perioperative_intravenous_lidocaine_for.45.aspx

Effect of perioperative intravenous lidocaine for patients...

The perioperative intravenous lidocaine was effective for reducing postoperative opioid consumption and pain in patients undergoing spine surgery.

5.

nassopenaccess.org

nassopenaccess.org/article/S2666-5484(21)00031-7/fulltext

Intravenous lidocaine in spine surgery: A meta-analysis of ...

This study aimed to evaluate the role of intravenous lidocaine as a supplemental pain control modality in patients undergoing spine surgery.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8819964/

Intravenous lidocaine in spine surgery: A meta-analysis of ...

Our results indicated that current literature does not support the use of intravenous lidocaine as an adjunctive measure of pain management after spine surgery.

7.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT05010148

A Clinical Trial of Intravenous Lidocaine After Spinal Surgery ...

A postoperative intravenous infusion of lidocaine, known to improve pain control in other contexts, can decrease the risk of postoperative delirium.

8.

mayoclinicproceedings.org

mayoclinicproceedings.org/article/S0025-6196(11)64644-2/fulltext

Potential Neurotoxicity of Spinal Anesthesia With Lidocaine

Available studies suggest a risk of persistent lumbosacral neuropathy after spinal lidocaine by single injection in about 1 in 1300 procedures.

9.

journals.lww.com

journals.lww.com/md-journal/fulltext/2018/03300/effect_of_intravenous_lidocaine_infusion_on.44.aspx

Effect of intravenous lidocaine infusion on long-term...

Our results suggest the role of lidocaine infusion as adjuncts to general anesthesia, it significantly, decreased long term postoperative back ...