Peritoneal nebulization of Ropivacaine for pain control after laparoscopic colectomy

INTERVENTION: Pharmaceutical Form: Solution for injection INN or Proposed INN: Ropivacaine Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 10‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intraperitoneal use Pharmaceutical Form: Solution for injection INN or Proposed INN: Morphine Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 10‐ Pharmaceutical Form: Solution for injection INN or Proposed INN: Ketoprofen Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 10‐ Pharmaceutical Form: Solution for injection INN or Proposed INN: Paracetamol Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 10‐ CONDITION: Elective Laparoscopic colectomy ; MedDRA version: 14.1 Level: LLT Classification code 10017633 Term: Gallbladder inflammation System Organ Class: 10019805 ‐ Hepatobiliary disorders Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: Assess if Ropivacaine nebulization (150 mg) produces better postoperative pain control than Saline nebulization (15 ml) after laparoscopic colectomy. Primary end point(s): Postoperative Pain Secondary Objective: Analgesic consumption during the first 72 hours after surgery; Time to unassisted walking; Incidence of adverse events; Return to active bowel function. Timepoint(s) of evaluation of this end point: 72 hours SECONDARY OUTCOME: Secondary end point(s): Consumption of analgesics and the total dose of analgesics in any assessment by the awakening in the recovery room and the ward will be calculated using the medical record. At each evaluation will also measure the proportion of patients requiring no morphine or requiring rescue dose. Time to unassisted ambulation time unassisted ambulation is defined as the time in hours between the discharge from the recovery room and when the patient is able to walk to the door of his room and go to bed without assistance. Resumption of intestinal function. The return of bowel function will be evaluated by two parameters: time of the first air passage and intestinal bowel movement the first time. The patient will be informed about the importance of notifying the first air passage and the first bowel movements. All hospital morbidity or complications associated with, or adverse effects associated with the intervention study, the surgery will be evaluated using the folder ol'anestesia cynical by the day of discharge from hospital wing. Timepoint(s) of evaluation of this end point: 72 hours INCLUSION CRITERIA: Females and Males 18‐80 years old; ASA Score I – III; A patient with severe systemic disease; Patients scheduled for laparoscopic colectomy; Diagnosis of colon cancer; patients free from pain in preoperative period; Patients who do not use opioids analgesic drugs before surgery; Patients without cognitive impairment or mental retardation; Patients who have given a written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50