Elective Laparoscopic colectomy MedDRA version: 14.1 Level: LLT Classification code 10017633 Term: Gallbladder inflammation System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
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 fo
Sponsors
AZIENDA OSPEDALIERA S. GERARDO DI MONZA
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Females and Males under 18 or over 80; ASA IV-V; Emergency/urgency surgery; Postoperative admission in an intensive care unit with sedation or ventilatory assistance; Cognitive impairment or mental retardation; Use of opiods before surgery; Progressive degenerative diseases of the CNS; Convulsions or chronic therapy with antiepileptic drugs; Severe hepatic or renal impairment; Pregnancy or lactation; Allergy to one of the specific drugs under study; Acute infection or inflammatory chronic disease; Alcohol or drug addiction; Any kind of communication problem; Neurologic or psychiatric disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess if Ropivacaine nebulization (150 mg) produces better postoperative pain control than Saline nebulization (15 ml) after laparoscopic colectomy.;Secondary Objective: Analgesic consumption during the first 72 hours after surgery; Time to unassisted walking; Incidence of adverse events; Return to active bowel function.;Primary end point(s): Postoperative Pain;Timepoint(s) of evaluation of this end point: 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactSperimentatore principale
Azienda Ospedaliera San Gerardo di Monza
Outcome results
None listed