KETAMINE AND DEXAMETHASONE IN THE MANAGEMENT OF LOW BACK PAIN DURING ARTHRODESIS

INTERVENTION: Trade Name: FORTECORTIN Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: AMETHASONE SODIUM PHOSPHATE Other descriptive name: DEXAMETHASONE SODIUM PHOSPHATE Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 0.1‐ Pharmaceutical form of the placebo: Concentrate and diluent for solution for infusion Route of administration of the placebo: Intravenous use Trade Name: KETOLAR Product Name: KETOLAR Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: KETAMINE HYDROCHLORIDE CAS Number: 1867‐66‐9 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 0.5‐ Pharmaceutical form of the placebo: Concentrate and diluent for solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Pain in the lumbar arthrodesis ; MedDRA version: 14.1 Level: PT Classification code 10061683 Term: Arthrodesis System Organ Class: 10042613 ‐ Surgical and medical procedures Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: The objective for this study is to evaluate the analgesic effects after administration of ketamine and intravenous dexamethasone perioperatively in patients undergoing lumbar arthrodesis and also, to study the incidence of pain and formalize perioperative analgesia. Primary end point(s): pain intensity will be assessed using the VAS questionnaire and consumption of morphine Secondary Objective: 1 Determine the effectiveness of ketamine and intravenous dexamethasone perioperatively in patients undergoing lumbar arthrodesis.; 2 Determine the incidence of pain: To study the reduction of acute postoperative pain, neuropathic pain and chronic pain in patients undergoing lumbar arthrodesis.; 3. Formalize the post‐operative analgesia Timepoint(s) of evaluation of this end point: pain intensity will be assessed by VAS questionnaire and morphine consumption the day before surgery, the same day of surgery and 3 months after the intervention SECONDARY OUTCOME: Secondary end point(s): There are no secondary endpoints Timepoint(s) of evaluation of this end point: Primary Endpoint will be assess once the patient completes participation in the study (3 months post intervention) INCLUSION CRITERIA: ? Male or female ? Age> 18 years ? ASA I‐III. ? lumbar arthrodesis. ? Patients who have signed informed consent before surgery, to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 128 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 128