Spinal Disease, Anesthesia, Post Operative Pain
Conditions
Keywords
Lidocaine, Intraoperative Neuromonitoring, Spine surgery, Post Operative Pain
Brief summary
The purpose of this study is to determine the effect of lidocaine infusion on intraoperative neuromonitoring in patients undergoing spine surgery.
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.
Interventions
Lidocaine infusion 1.5 mg/kg/hr
DRUGNormal saline
Normal saline infusion
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor Evoked Potentials (MEPs) | Duration of the surgical procedure, no more than 24 hours | An endpoint of the final stimulation threshold for MEPs at the end of surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Somatosensory Evoked Potentials (SSEPs) | Duration of the surgical procedure, no more than 24 hours | Endpoints of amplitude and latency throughout the surgery of SSEPs |
| Mean Arterial Pressure (MAP) | Duration of the surgical procedure, no more than 24 hours | Intraoperative incidence of MAP \<65 mmHg and MAP \< 55 mmHg |
| Intraoperative propofol consumption | Duration of the surgical procedure, no more than 24 hours | Rate of propofol consumption between the arms |
| Visual Analog Scale (VAS) Pain Scores | Post-operative day 0 through 3 | Endpoint of VAS pain scores post operative days (POD) 0/1/3 |
| Opiod consumption | Post-operative day 0 through 3 | Opiod consumption converted to morphine equivalents through post operative day (POD) 3 |
Countries
United States
Contacts
Primary ContactLauren K Buhl, MD, PhD
Outcome results
None listed