Peritoneal nebulization of Ropivacaine for postoperative pain control after laparoscopic cholecystectomy A multicentre, randomized, controlled, double blinded, phase III clinical trial; comparing preoperative peritoneal nebulization of Ropivacaine 100 mg or 150 mg with preoperative peritoneal nebulization of Ropivacaine 50 mg in the peritoneal cavity - AR HSG 01 2010

• Conditions: Elective Laparoscopic cholecystectomy; MedDRA version: 12.1Level: LLTClassification code 10008611Term: Cholecystectomy

• Registration Number: EUCTR2009-018247-24-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SAN GERARDO DI MONZA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-29
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Females and Males 18-75 years old; ASA Score I-III; severe systemic disease; patients scheduled for laparoscopic cholecystectomy; free from pain in preoperative period; patients who do not use 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Females and Males under 18 or over 75; 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 analgesic drugs 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; no written informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified