anesthetic strategy for control of postoperative pain for laparoscopic colectomy

Conditions: MedDRA version: 14.1Level: LLTClassification code 10017633Term: Gallbladder inflammationSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Elective Laparoscopic colectomy

Registration Number: EUCTR2010-021240-18-IT

Lead Sponsor: AZIENDA OSPEDALIERA S. GERARDO DI MONZA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures