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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine Infusion (Active) | Active Comparator | Lidocaine infusion |
|
| Normal Saline Infusion (Sham) | Sham Comparator | Normal saline infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine in Saline | Drug | Lidocaine infusion 1.5 mg/kg/hr |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren K Buhl, MD, PhD | Contact | 603-650-5922 | lauren.k.buhl@hitchcock.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23996498 | Background | 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. | |
| 28666848 | 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. |
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| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| D015444 | Exercise |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Single-center, double-blinded, randomized trial with randomization to lidocaine infusion or saline infusion for patients undergoing spine surgery with intraoperative neurophysiological monitoring
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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.
| Normal saline | Drug | Normal saline infusion |
|
|
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 |
| 28114177 | 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. |
| 27005275 | 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. |
| 34457261 | 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. |
| 15087620 | 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. |
| 28403408 | 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. |
| 23681143 | 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. |
| 1386560 | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |