Lidocaine Infusion With ANI Monitoring in Spine Surgery.

Study Overview
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Brief Summary
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To evaluate the analgesic effect of intraoperative continuous lidocaine infusion (1.5 mg/kg/h (ideal body weight)) in combination of analgesia nociception index and depth of anesthesia monitors guided anesthetics adjustment on enhanced recovery after surgery (ERAS) in patients undergoing elective lumbar spine surgery (≥2 sessions).

Detailed Description
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The patients undergoing elective lumbar spine surgery (≥2 sessions) are randomly assigned and divided patients into two groups according to the allocation sequence table (corresponding to 1:1 randomization) generated by the computer. Patients in the lidocaine group receive an intravenous injection of 1.5 mg/kg lidocaine at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation. Patients in control group receive the same volume of saline injection. During the operation, the dose of anesthetic drugs (propofol, remifentanil and rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value, Entropy (or BIS) value at 40-60, and ANI at 50-70 in both groups. The pain score (numerical rating scale), cumulative amount of opioids used after the operation within 3 days, and the quality of recovery on the third day after the operation are recorded and analyzed.

Official Title
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The Analgesic Effect of Intravenous Lidocaine Infusion in Combination of Analgesia Nociception Index Monitoring in Spine Surgery.

Conditions
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Spine Surgery

Intervention / Treatment
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* Drug: Lidocaine HCl 2%
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Twenty to eighty-year-old ASA class I-III patients undergoing Elective lumbar spine surgery under general anesthesia Exclusion Criteria: Unable to understand the Numerical Rating Scale (NRS) Severe mental disorder Poor liver function Pregnant or lactating women Morbidly obese History of epilepsy or allergy to any of the drugs used in this study Current use of opioids Baseline heart rate <50 beats/min Arrhythmia history with cardiac rhythm device Body weight <40 kg and >80kg

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine group<br>Patients in the lidocaine group receive an intravenous injection of 1.5 mg/kg Lidocaine HCl 2% at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation. | Drug: Lidocaine HCl 2%<br>* Intravenous injection of 1.5 mg/kg lidocaine at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation.<br>* Other names: Xylocaine Injection 2%;|
| Placebo Comparator: control group<br>Patients in control group receive the same volume of saline injection. | Drug: Normal saline<br>* Intravenous injection of 1.5 mg/kg normal saline at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation.<br>* Other names: 0.9% Normal Saline (20mL);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative amount of opioids used | cumulative amount of opioids used after the operation | within 48 hours after operation | 
| the quality of recovery after the operation | Quality of recovery-15 score, QoR-15, 0-150, higher score means better outcome | on the third day after the operation | 
| pain score | numerical rating scale, NRS, 0-10, higher score means worse outcome | within 72 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative amount of opioids used | cumulative amount of opioids used after the operation | within 72 hours after operation | 
| cumulative amount of propofol used | cumulative amount of propofol used | during operation | 
| cumulative amount of remifentanil used | cumulative amount of remifentanil used | during operation | 
| cumulative amount of rocuronium used | cumulative amount of rocuronium used | during operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lidocaine, enhanced recovery after surgery