Comparison of the Effect of Lidocaine Infusion Applied at Different Doses During Lumbar Spinal Surgery on Hemodynamics and Postoperative Pain

Study Overview
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Brief Summary
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The aim of this study is to investigate the effects of intravenous infusion of lidocaine at different doses (1 mg/kg/h vs. 2 mg/kg/h) in the intraoperative period in patients undergoing lumbar stabilization, whether postoperative pain, postoperative opioid use, opioid-related side effects are reduced, and its effects on intraoperative hemodynamics

Detailed Description
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Lumbar stabilization surgery is among the surgical interventions with a high incidence of postoperative pain. Controlling postoperative pain and ensuring early recovery are important in terms of early neurological evaluation. It has been shown that lidocaine infusion administered during the intraoperative period causes peripheral vasodilation, synaptic transmission inhibition, and an increase in the depth of anesthesia. Because of these effects, the effects of lidocaine infusion on hemodynamic responses and recovery have been investigated. The safe dose range of lidocaine is 1-4 mg/kg, and the toxic dose is 5 mg/kg and above. Many studies have shown that lidocaine infusion suppresses the sympathetic reflex response and has a depressive effect on the cardiovascular system. In a study evaluating patients who underwent open radical prostatectomy surgery, it was found that blood pressure values were lower in patients who received intraoperative lidocaine infusion compared to the control group. In a study evaluating 60 female patients who underwent breast surgery, it was shown that the mean blood pressure value was significantly lower in patients who received lidocaine infusion. Lidocaine infusion has been applied at different doses (2-3 mg/kg/hour) and at different times in different surgical procedures, and it has been shown to be more effective in reducing postoperative pain, especially in some surgical procedures. Studies showing that lidocaine infusion provides early recovery in the perioperative period; They explain this effect of lidocaine by reducing the need for opioids and reducing the complications that affect the quality of recovery, such as opioid-related nausea and vomiting. It has been shown that 2 mg/kg/hour lidocaine infusion in patients undergoing vertebral surgery provides early and high-quality recovery by reducing the opioid requirement and reducing pain scores. In a study conducted in patients undergoing spinal fusion surgery, lidocaine was administered as a bolus of 2 mg/kg in the induction of anesthesia and infusion of 3 mg/kg/hour in the intraoperative period until the end of the surgery. Compared to the control group, the first additional analgesic need emerged later and the total amount of morphine consumption was found to be lower. Although there are studies in the literature using different doses of lidocaine in different surgeries, there are limited data on the effect of different doses of lidocaine on intraoperative postoperative pain and hemodynamics in patients who underwent vertebral surgery. In our study, we aimed to investigate the effect of different doses of lidocaine infusion (1 mg/kg/hour and 2 mg/kg/hour) on postoperative pain changes and hemodynamics. The main aim of the study is to evaluate whether 2 mg/kg/h lidocaine infusion doses reduce postoperative pain severity more than 1 mg/kg/h infusion doses in patients undergoing lumbar stabilization surgery.

Official Title
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Comparison of the Effect of Lidocaine Infusion Applied at Different Doses During Lumbar Spinal Surgery on Hemodynamics and Postoperative Pain

Conditions
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Post Operative Pain, Opioid Use, Hemodynamic Instability

Intervention / Treatment
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* Drug: Lidocaine IV
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1,2 Exclusion Criteria: ASA 3,4,5 Pediatric Patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group L1<br>Group who gets 1 mg/kg/min IV lidocaine infusion during surgery | Drug: Lidocaine<br>* Intravenous infusion rate of lidocaine is 1 mg/kg/min<br>|
| Experimental: Group L2<br>Group who gets 2 mg/kg/min IV lidocaine infusion during surgery | Drug: Lidocaine IV<br>* Intravenous infusion rate of lidocaine is 2 mg/kg/min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing Postoperative pain with the pain scoring system (Visual Pain Scale). | The primary endpoint was the evaluation and comparison of two different infusion doses (2 mg/kg/hr and 1 mg/kg/hr) of postoperative pain with the pain scoring system (Visual Pain Scale). | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring Intraoperative blood pressure | The secondary endpoint was to determine and compare the effect of two different infusion doses on intraoperative blood pressure | 2 hours | 
| Monitoring intraoperative heart rate | The secondary endpoint was to determine and compare the effect of two different infusion doses on intraoperative heart rate | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lidocaine, infusion, postoperative pain, lumbar surgery