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

44 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug lidocaine for spinal diseases?

Research shows that lidocaine is effective in reducing acute low back pain, with high response rates and no side effects. Additionally, studies indicate that lidocaine can improve recovery quality and reduce pain after spinal surgery. ^{1 2 3 4 5}

Is lidocaine safe for use in spinal anesthesia?

Lidocaine has been used for spinal anesthesia for many years, but it has been linked to some safety concerns. It can cause transient neurological symptoms (temporary nerve-related issues) and, in rare cases, more serious conditions like cauda equina syndrome (a severe nerve condition). While these issues are uncommon, they are more frequent with lidocaine compared to other anesthetics. ^{6 7 8 9 10}

How does the drug lidocaine differ from other treatments for spinal diseases?

Lidocaine is unique for spinal diseases because it can be delivered directly into the spinal cord tissue (intraparenchymal injection), which may provide targeted anti-inflammatory effects without affecting neurons or causing inflammation, unlike other treatments that might be administered systemically or intrathecally (into the spinal fluid). ^{2 6 10 11 12}

What is the purpose of this trial?

The purpose of this study is to determine the effect of lidocaine infusion on intraoperative neuromonitoring in patients undergoing spine surgery.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Therapeutic local anesthesia in acute back pain]. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of an Intraparenchymal Injection of Lidocaine in the Rat Cervical Spinal Cord. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Effect of systemic lidocaine on postoperative quality of recovery, the gastrointestinal function, inflammatory cytokines of lumbar spinal stenosis surgery: a randomized trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Perioperative Intravenous Lidocaine Infusion for Postoperative Analgesia in Patients Undergoing Surgery of the Spine: Systematic Review and Meta-Analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of perioperative intravenous lidocaine administration on pain, opioid consumption, and quality of life after complex spine surgery. [2014]

6. England pubmed.ncbi.nlm.nih.gov

Transient neurological symptoms with subarachnoid lidocaine: effect of early mobilization. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Potential neurotoxicity of spinal anesthesia with lidocaine. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

AANA Journal course: transient neurologic symptoms and spinal anesthesia. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Single-dose lidocaine spinal anesthesia in hip and knee arthroplasty. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Should intrathecal lidocaine be used in the 21st century? [2022]

11. England pubmed.ncbi.nlm.nih.gov

Hyperbaric articaine for day-case spinal anaesthesia. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Lidocaine concentrations in plasma and cerebrospinal fluid after systemic bolus administration in humans. [2019]