Influence of Lidocaine Infusion on Motor Evoked Potential Thresholds

NCT06792474 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY02002708
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Disease; Anesthesia; Post Operative Pain

Keywords

Lidocaine; Intraoperative Neuromonitoring; Spine surgery; Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Somatosensory Evoked Potentials (SSEPs)

  Duration of the surgical procedure, no more than 24 hours

• Mean Arterial Pressure (MAP)

  Duration of the surgical procedure, no more than 24 hours

• Intraoperative propofol consumption

  Duration of the surgical procedure, no more than 24 hours

• Visual Analog Scale (VAS) Pain Scores

  Post-operative day 0 through 3

• Opiod consumption

  Post-operative day 0 through 3

Study Arms (2)

Lidocaine Infusion (Active)

ACTIVE COMPARATOR

Lidocaine infusion

Drug: Lidocaine in Saline

Normal Saline Infusion (Sham)

SHAM COMPARATOR

Normal saline infusion

Drug: Normal saline

Interventions

Lidocaine in Saline DRUG

Lidocaine infusion 1.5 mg/kg/hr

Also known as: Active

Lidocaine Infusion (Active)

Normal saline DRUG

Normal saline infusion

Also known as: Placebo

Normal Saline Infusion (Sham)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Related Publications (9)

• 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.

  PMID: 23996498 BACKGROUND

• 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.

  PMID: 28666848 BACKGROUND

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

  PMID: 28114177 BACKGROUND

• 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.

  PMID: 27005275 BACKGROUND

• 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.

  PMID: 34457261 BACKGROUND

• 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.

  PMID: 15087620 BACKGROUND

• 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.

  PMID: 28403408 BACKGROUND

• 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.

  PMID: 23681143 BACKGROUND

• 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.

  PMID: 1386560 BACKGROUND

MeSH Terms

Conditions

Spinal Diseases; Pain, Postoperative

Interventions

Lidocaine; Sodium Chloride; Exercise; Saline Solution

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Lauren K Buhl, MD, PhD

CONTACT

603-650-5922; lauren.k.buhl@hitchcock.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The Research Pharmacy will compound lidocaine 2,000 mg (4 mg/mL) in 500 mL 0.9% sodium chloride or placebo (infusion bags will be aseptically prepared in a biological safety cabinet.) The lidocaine or placebo bags will be delivered and stored in the Same Day Procedure Omnicell machine prior to the day of procedure. The infusion bags will not be labeled as lidocaine or placebo in order not to unblind the blinded personnel administering the investigational product and will contain the calculated rate of infusion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-center, double-blinded, randomized trial with randomization to lidocaine infusion or saline infusion for patients undergoing spine surgery with intraoperative neurophysiological monitoring

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 24, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)