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AzTrials

Spinal DiseasePhase 4NCT06792474

Influence of Lidocaine Infusion on Motor Evoked Potential Thresholds

A Phase 4 study testing Lidocaine in Saline and Normal saline in people with Spinal Disease and Anesthesia, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Spinal Disease, Anesthesia, Post Operative Pain
What is being tested?
Lidocaine in Saline and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteUnited States
Study dates
Aug 2026to Aug 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients undergoing elective cervical or thoracolumbar spine surgery with intraoperative neurophysiological monitoring

Who cannot join

  • Inability to provide informed consent in English
  • Pregnancy (based on patient report or a positive test on the day of surgery)
  • Contraindication to lidocaine
  • Planned post-operative intubation
  • Current incarceration

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lauren K Buhl, MD, PhD contact

603-650-5922

lauren.k.buhl@hitchcock.org

United States1 site

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

    Lauren Buhl, MD, PhD, 603-650-5000, lauren.k.buhl@hitchcock.org

Other trials in United States

About this study

Official title: Influence of Lidocaine Infusion on Motor Evoked Potential Thresholds; a Single-center, Double-blinded, Randomized Trial for Patients Undergoing Spin Surgery With Intraoperative Neurophysiologic Monitoring.

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

Read the detailed description

The investigators will compare the stimulation threshold for motor evoked potentials (MEPs) for patients undergoing spine surgery with intraoperative neurophysiologic monitoring (IONM) who receive a lidocaine infusion vs. normal saline (NS) infusion. The endpoint for this objective will be the final stimulation threshold for MEPs at the end of the surgery. The stimulation threshold for MEPs is a commonly used metric to determine the effects of anesthetic agents on MEP signals. Secondary objectives will somatosensory evoked potentials (SSEPs) with an endpoint of amplitude and latency of SSEPs throughout the surgery. Other secondary outcomes will include, intraoperative mean arterial pressure (MAP), intraoperative propofol consumptions, and post-operative visual analog scale (VAS) and opioid consumption.

Being tested
Lidocaine in Saline, Normal saline
Keywords
Lidocaine, Intraoperative Neuromonitoring, Spine surgery, Post Operative Pain
Medical subject headings
Spinal Diseases, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lidocaine in SalineDrug

    Also called Active

    Lidocaine infusion 1.5 mg/kg/hr

  • Normal salineDrug

    Also called Placebo

    Normal saline infusion

Study groups in NCT06792474
Study groupRoleWhat they receive
Lidocaine Infusion (Active)Active comparatorLidocaine infusion
Receives: Drug: Lidocaine in Saline
Normal Saline Infusion (Sham)Sham comparatorNormal saline infusion
Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Motor Evoked Potentials (MEPs)

    An endpoint of the final stimulation threshold for MEPs at the end of surgery.

    Measured: Duration of the surgical procedure, no more than 24 hours

Secondary outcomes (5)

  1. Somatosensory Evoked Potentials (SSEPs)

    Endpoints of amplitude and latency throughout the surgery of SSEPs

    Measured: Duration of the surgical procedure, no more than 24 hours

  2. Mean Arterial Pressure (MAP)

    Intraoperative incidence of MAP <65 mmHg and MAP < 55 mmHg

    Measured: Duration of the surgical procedure, no more than 24 hours

  3. Intraoperative propofol consumption

    Rate of propofol consumption between the arms

    Measured: Duration of the surgical procedure, no more than 24 hours

  4. Visual Analog Scale (VAS) Pain Scores

    Endpoint of VAS pain scores post operative days (POD) 0/1/3

    Measured: Post-operative day 0 through 3

  5. Opiod consumption

    Opiod consumption converted to morphine equivalents through post operative day (POD) 3

    Measured: Post-operative day 0 through 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2025
  2. Study startAug 2026 (estimated)
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

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
Model description
Single-center, double-blinded, randomized trial with randomization to lidocaine infusion or saline infusion for patients undergoing spine surgery with intraoperative neurophysiological monitoring
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06792474
Sponsor's protocol ID
STUDY02002708
Status last verified
Nov 2025
First submitted
26 Dec 2024
Last updated
24 Nov 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sloan TB, Mongan P, Lyda C, Koht A. Lidocaine infusion adjunct to total intravenous anesthesia reduces the total dose of propofol during intraoperative neurophysiological monitoring. J Clin Monit Comput. 2014 Apr;28(2):139-47. doi: 10.1007/s10877-013-9506-x. Epub 2013 Aug 31.

    PubMed 23996498

  • Urban MK, Fields K, Donegan SW, Beathe JC, Pinter DW, Boachie-Adjei O, Emerson RG. A randomized crossover study of the effects of lidocaine on motor- and sensory-evoked potentials during spinal surgery. Spine J. 2017 Dec;17(12):1889-1896. doi: 10.1016/j.spinee.2017.06.024. Epub 2017 Jun 27.

    PubMed 28666848

  • Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available.

    PubMed 28114177

  • Leliefeld PH, Wessels CM, Leenen LP, Koenderman L, Pillay J. The role of neutrophils in immune dysfunction during severe inflammation. Crit Care. 2016 Mar 23;20:73. doi: 10.1186/s13054-016-1250-4.

    PubMed 27005275

  • Karnina R, Arif SK, Hatta M, Bukhari A. Molecular mechanisms of lidocaine. Ann Med Surg (Lond). 2021 Aug 17;69:102733. doi: 10.1016/j.amsu.2021.102733. eCollection 2021 Sep.

    PubMed 34457261

  • Hollmann MW, Herroeder S, Kurz KS, Hoenemann CW, Struemper D, Hahnenkamp K, Durieux ME. Time-dependent inhibition of G protein-coupled receptor signaling by local anesthetics. Anesthesiology. 2004 Apr;100(4):852-60. doi: 10.1097/00000542-200404000-00015.

    PubMed 15087620

  • Dewinter G, Moens P, Fieuws S, Vanaudenaerde B, Van de Velde M, Rex S. Systemic lidocaine fails to improve postoperative morphine consumption, postoperative recovery and quality of life in patients undergoing posterior spinal arthrodesis. A double-blind, randomized, placebo-controlled trial. Br J Anaesth. 2017 Apr 1;118(4):576-585. doi: 10.1093/bja/aex038.

    PubMed 28403408

  • Farag E, Ghobrial M, Sessler DI, Dalton JE, Liu J, Lee JH, Zaky S, Benzel E, Bingaman W, Kurz A. Effect of perioperative intravenous lidocaine administration on pain, opioid consumption, and quality of life after complex spine surgery. Anesthesiology. 2013 Oct;119(4):932-40. doi: 10.1097/ALN.0b013e318297d4a5.

    PubMed 23681143

  • Schubert A, Licina MG, Glaze GM, Paranandi L. Systemic lidocaine and human somatosensory-evoked potentials during sufentanil-isoflurane anaesthesia. Can J Anaesth. 1992 Jul;39(6):569-75. doi: 10.1007/BF03008320.

    PubMed 1386560

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lidocaine in Saline and Normal saline in people with Spinal Disease and Anesthesia, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lauren K Buhl, MD, PhD (603-650-5922, lauren.k.buhl@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motor Evoked Potentials (MEPs) (time frame: Duration of the surgical procedure, no more than 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06792474, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.

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