Influence of Lidocaine Infusion on Motor Evoked Potential Thresholds

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia; Post Operative Pain; Spinal Disease
• Intervention / Treatment: Drug: Normal saline; Drug: Lidocaine in Saline

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lauren K Buhl, MD, PhD; Phone Number: 603-650-5922; Email: lauren.k.buhl@hitchcock.org

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth Hitchcock Medical Center
      • Contact: Lauren Buhl, MD, PhD; Phone Number: 603-650-5000; Email: lauren.k.buhl@hitchcock.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine Infusion (Active); Lidocaine infusion	Drug: Lidocaine in Saline; Lidocaine infusion 1.5 mg/kg/hr; Other Names: Active
Sham Comparator: Normal Saline Infusion (Sham); Normal saline infusion	Drug: Normal saline; Normal saline infusion; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Evoked Potentials (MEPs)	An endpoint of the final stimulation threshold for MEPs at the end of surgery.	Duration of the surgical procedure, no more than 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Somatosensory Evoked Potentials (SSEPs)	Endpoints of amplitude and latency throughout the surgery of SSEPs	Duration of the surgical procedure, no more than 24 hours
Mean Arterial Pressure (MAP)	Intraoperative incidence of MAP <65 mmHg and MAP < 55 mmHg	Duration of the surgical procedure, no more than 24 hours
Intraoperative propofol consumption	Rate of propofol consumption between the arms	Duration of the surgical procedure, no more than 24 hours
Visual Analog Scale (VAS) Pain Scores	Endpoint of VAS pain scores post operative days (POD) 0/1/3	Post-operative day 0 through 3
Opiod consumption	Opiod consumption converted to morphine equivalents through post operative day (POD) 3	Post-operative day 0 through 3

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: December 26, 2024
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Lidocaine; Spine surgery; Post Operative Pain; Intraoperative Neuromonitoring
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Spinal Diseases; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Organic Chemicals; Pharmaceutical Preparations; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Inorganic Chemicals; Chlorine Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Sodium Compounds; Chlorides; Hydrochloric Acid; Lidocaine; Exercise; Saline Solution; Sodium Chloride
• Other Study ID Numbers: STUDY02002708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No