Do peritoneal nebulization of Ropivacaine reduce the use of morphine after short gynecologic laparoscopic surgery? A multicentre, randomized, controlled, double blinded, phase III clinical trial; comparing preoperative peritoneal nebulization of Ropivacaine 150 mg with preoperative peritoneal instillation of Ropivacaine 150 mg in the peritoneal cavity. - AR HSG 02 2010
- Conditions
- Elective ovarian cyst laparoscopic surgeryMedDRA version: 9.1Level: PTClassification code 10033132
- Registration Number
- EUCTR2010-018693-20-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA SAN GERARDO DI MONZA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Females 18-65 years old; ASA Score I III; Patients scheduled for ovarian cyst laparoscopic surgery; 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) no
F.1.3.1 Number of subjects for this age range
Females under 18 or over 65; 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Asses if preoperative nebulization of Ropivacaine (150 mg) comparing with preoperative instillation of Ropivacaine (150 mg) reduced the use of morphine in the first day after ovarian cyst laparoscopic surgery;Secondary Objective: Intensity of Postoperative Pain; Time of unassisted walking; Incidence of adverse events; Time and condition for hospital discharge; Quality of life four weeks after surgery;Primary end point(s): Morphine consumption
- Secondary Outcome Measures
Name Time Method