Management of Pain in Lumbar Arthrodesis

Study Overview
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Brief Summary
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KETAMINE AND DEXAMETASONE IN THE MANAGEMENT OF PAIN IN LUMBAR ARTHRODESISPhase IV prospective randomized controlled single-center clinical trial to determine the effect of intravenous ketamine and dexamethasone administration perioperatively in patients undergoing lumbar arthrodesis.

Detailed Description
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The need to carry out this study is to evaluate the analgesic effects after the administration of ketamine and dexamethasone intravenously perioperatively in patients undergoing lumbar arthrodesis and, likewise, study the incidence of pain and protocolize perioperative analgesia.

Official Title
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Ketamine and Dexametasone in the Management of Pain in Lumbar Arthrodesis

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Ketamine
* Drug: Dexamethasone
* Drug: Physiologic saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Age> 18 years ASA I-III. Lumbar arthrodesis. Patients who have signed the preoperative informed consent for participation in the study. Exclusion Criteria: Unstable coronary heart disease Glaucoma History of allergy to ketamine, dexamethasone, or morphic chloride Dementia or inability to understand IC and study Pluricomplicated diabetes mellitus difficult to control Patients who have taken an experimental drug 30 days before the start of the study or who are included in any type of study of an experimental drug

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Single-center, controlled, prospective and randomized clinical trial, phase IV, to determine the effect of perioperative intravenous administration of ketamine and dexamethasone in patients undergoing lumbar arthrodesis
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamina bolus plus Dexamethasone bolus plus infusion ketamine<br>Ketamine bolus (0.5 mg / kg) + dexamethasone 0.1 mg / kg bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the Post-Anesthesia Resuscitation Unit (URPA) | Drug: Ketamine<br>* Ketamine, being a non-competitive antagonist of NMDA receptors, could represent a good option as an opioid treatment enhancer for acute postoperative pain and avoid chronic pain, by reducing the '' wind-up '' phenomenon of central sensitization<br>Drug: Dexamethasone<br>* A meta-analysis published in September 2011 affirms that the administration of dexamethasone at a dose of 0.1 mg / kg is an effective complement to multimodal analgesia strategies to reduce postoperative pain and opioid consumption after surgery. Preoperative administration of the drug produces a more consistent analgesic effect than intraoperative administration<br>|
| Experimental: Ketamine bolus plus ketamine infusion<br>Ketamine bolus (0.5 mg / kg) + physiological serum bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the URPA. | Drug: Ketamine<br>* Ketamine, being a non-competitive antagonist of NMDA receptors, could represent a good option as an opioid treatment enhancer for acute postoperative pain and avoid chronic pain, by reducing the '' wind-up '' phenomenon of central sensitization<br>Drug: Physiologic saline<br>* placebo<br>|
| Active Comparator: Dexametasone arm<br>Saline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA | Drug: Dexamethasone<br>* A meta-analysis published in September 2011 affirms that the administration of dexamethasone at a dose of 0.1 mg / kg is an effective complement to multimodal analgesia strategies to reduce postoperative pain and opioid consumption after surgery. Preoperative administration of the drug produces a more consistent analgesic effect than intraoperative administration<br>Drug: Physiologic saline<br>* placebo<br>|
| Placebo Comparator: Saline bolus<br>Saline bolus + saline bolus + saline infusion up to three hours after admission to the URPA | Drug: Physiologic saline<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Morphic Chloride (PCA) to treat pain during the post-operative period. Consumption of morphics will be evaluated | Consumption of morphics | 4 hours post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative nausea and vomiting (PONV). | Incidence of postoperative nausea and vomiting | 4 hours post operative | 
| Efficay of study treatment regarding pain at 3 postoperative months | Pain at 3 postoperative months assessed by EVA scale pain. This is a visual analogue scale regarding pain.It consists of a 10-centimeter horizontal line, at the ends of which are the extreme expressions of a symptom. In the left is the absence or less intensity and in the right the greater intensity. The patient is asked to mark on the line the point that indicates the intensity and measure it with a millimeter ruler. The intensity is expressed in centimeters or millimeters. The evaluation will be: 1.Mild pain if the patient scores pain less than 3. 2.Moderate pain if the evaluation is between 4 and 7. 3.Severe pain if the evaluation is equal to or greater than 8. | 3 months | 
| Adverse side effects:Hallucinations / Delirium.Sedation. Diplopia, Hyperglycemia Respiratory depression (Sat <90%) | Rate of patients that presented adverse events | 4 hours post operative |