The effect of chlorzoxazone of moderate to severe postoperative pain after back surgery

INTERVENTION: Trade Name: Chlorzoxazon Product Name: Chlorzoxason Pharmaceutical Form: Tablet INN or Proposed INN: CHLORZOXAZONE CAS Number: 95‐25‐0 Other descriptive name: Chlorzoxazon Concentration unit: mg milligram(s) Concentration type: range Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Patients set to back surgery in general anesthesia ; MedDRA version: 16.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: Our purpose is to investigate the effect of chlorzoxazone of moderate to severe postoperative pain after spine surgery. Our hypothesis is that chlorzoxazone may reduce postoperative pain, as well as reduce opioidforbrug and adverse reactions compared to placebo. Primary end point(s): Pain Score of active mobilization (VAS) defined by standardized movement from supine to sitting on the edge of the bed on time 2 hours after the intake of chlorzoxazone. Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: 2 hours after intake of studymedication SECONDARY OUTCOME: Secondary end point(s): The total need for morphine from 0 to 4 hours after administration of the studymedication administered as patient‐controlled pain management (PCA bolus 2.5 mg, lockout 10 minutes) and escape morphine.; Pain Score at rest (VAS) at time 1, 2, 3 and 4 hours, calculated as the area under the curve (AUC) from 1‐4 hours after intake of studymedication.; Pain Score of active mobilization (VAS) defined by a standardized movement from supine to sitting on the edge of the bed on time 1, 2, 3 and 4 hours, calculated area under the curve from 1‐4 hours after intake of studymedication .; The degree of nausea at time 1, 2, 3 and 4 hours after intake of study medication.; The degree of dizziness at time 1, 2, 3 and 4 hours after taking the medicine project; Number of vomiting during the periods 0‐4 hours after intake of studymedication.; consumption of Zofran over the period 0‐4 hours after intake of study medication.; Degree of sedation at time 1, 2, 3 and 4 hours after intake of study medication. Timepoint(s) of evaluation of this end point: 1,2,3 and 4 hours after intake of study medication INCLUSION CRITERIA: The patient has undergone back surgery in general anesthesia Postoperative VAS score of active mobilization defined by standardized movement from supine to sitting on the edge of the bed> 50 mm, measured on awakening or ward Have not received pain medication one hour prior to study entry Age> 18 and <85 years ASA 1‐3. BMI> 18 and <40 For women of childbearing age requirement they must have a negative urine HCG pregnancy test. Patients who have given written informed consent to participate in the study after to have understood the contents of the protocol and limitations in full. 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 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35