Influence of Lidocaine Infusion on Motor Evoked Potential Thresholds

NCT ID: NCT06792474

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-08-31

Study Completion Date

2027-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Spinal Disease Anesthesia Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center, double-blinded, randomized trial with randomization to lidocaine infusion or saline infusion for patients undergoing spine surgery with intraoperative neurophysiological monitoring
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

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Lidocaine Infusion (Active)

Lidocaine infusion

Group Type ACTIVE_COMPARATOR

Lidocaine in Saline

Intervention Type DRUG

Lidocaine infusion 1.5 mg/kg/hr

Normal Saline Infusion (Sham)

Normal saline infusion

Group Type SHAM_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline infusion

Interventions

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Lidocaine in Saline

Lidocaine infusion 1.5 mg/kg/hr

Intervention Type DRUG

Normal saline

Normal saline infusion

Intervention Type DRUG

Other Intervention Names

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Active Placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Lauren K. Buhl

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Central Contacts

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Lauren K Buhl, MD, PhD

Role: CONTACT

603-650-5922

Facility Contacts

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Lauren Buhl, MD, PhD

Role: primary

603-650-5000

References

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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.

Reference Type BACKGROUND
PMID: 23996498 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28666848 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 28114177 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27005275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34457261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15087620 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28403408 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23681143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1386560 (View on PubMed)

Other Identifiers

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STUDY02002708

Identifier Type: -

Identifier Source: org_study_id

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