Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion

Study Overview
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Brief Summary
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Spinal fusion is a painful surgery, and control of postoperative pain is difficult. Several studies have indicated that appropriate pain treatment protocols reduce postoperative morbidity, improve the results of the surgery, and decrease hospital costs

Detailed Description
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Forty four patients were randomly allocated into two groups of equal size to receive either lidocaine infusion (Lidocaine group) or 0.9% sodium chloride infusion (Control group). Randomization: was performed using Lidocaine group and Control group registers, which was placed in sealed envelopes prior to study initiation and opened prior to anesthesia by a physician who prepared the intravenous solution and identified it with the patient number, according to the envelope drawn. The solution was handed to another physician, blind to the prepared solutions' content, who was responsible for the anesthesia. The solution volume was equal. The responsible investigator was remained blind to the chosen group until the end of the study.

Official Title
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Effect of Intravenous Lidocaine Infusion on Long Term Postoperative Pain After Spinal Fusion Surgery

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: 0.9% Sodium-chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years American Society of Anesthesiologists 1-3 status Patients undergoing spinal fusion or fixation Exclusion Criteria: Previous spinal fusion surgery. Morbid obesity (BMI > 40) Diagnosis of spinal metastatic cancer Allergy to an amide local anesthetic or morphine sulfate History of renal dysfunction, liver dysfunction or congestive heart failure History of substance abuse disorder. Chronic opioid use.

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Active Comparator: Lidocaine group<br>Patients will receive lidocaine infusion. | Drug: Lidocaine<br>* patients (n = 20) will receive a loading dose of lidocaine 2 mg ̸ kg slowly IV just before induction of anesthesia, then the lidocaine infusion started at a rate of 3 mg ̸ kg/h, and continued until the end of the operation.<br>* Other names: Xylocaine;|
| Placebo Comparator: Control group<br>Patients will receive 0.9% Sodium-chloride infusion infusion | Drug: 0.9% Sodium-chloride<br>* patients (n = 20) will receive an equal volume of 0.9% saline (both the loading and the infusion), the infusion will be initiated at the time of induction of anesthesia and continued until the end of the operation.<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numerical rating scale (NRS), pain score. | Postoperative numerical rating scale (NRS), pain score. | Postoperative 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption. | Postoperative opioid consumption. | Postoperative 24 h | 
| Serum cortisol. | Serum cortisol level. | Postoperative 24 h |