Intra and post operatorive period MedDRA version: 9.1 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders
Conditions
Sponsors
A.O. SAN GERARDO DI MONZA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Females 18-70 years old - ASA I, II, III - Free from pain during the preoperatorive period - No usual assumption of analgesic drugs - Patients without cognitive impairment or mental retardation - 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
Exclusion criteria
Exclusion criteria: Males and Females under 18 or over 70 ASA Score IV (American Society of Anesthesiologists classification (Appendix 1): A patient with severe systemic disease that is a constant threat to life ASA Score V (American Society of Anesthesiologists classification (Appendix 1): A moribund patient who is not expected to survive without the operation Emergency/urgency criteria Postoperative admission in a intensive care unit with sedation or ventilatory assistance Cognitive impairment or mental retardation Habitual use of analgesic analgesic drugs 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 substances used in the study Acute infectious disease or inflammatory chronic disease Alcohol or drug addiction Any kind of communication problem Neurologic or psychiatric disease No written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint of the study is to determine if ropivacaine nebulization in CO2 used for abdominal inflation can reduce the postoperatorive pain within the first 48 hours after laparoscopic cholecystectomy;Secondary Objective: The secondary endpoint of the study is to determine if preoperative and/or postoperative ropivacaine nebulization in patients undergoing laparoscopic cholecystectomy is more effective than preoperative direct instillation in peritoneum in order to: Reduce anesthetic and analgesic consumption during surgery Reduce the central temperature loss during surgery Reduce the analgesic consumption after surgery Return earlier to walking after surgery Reduce hospitalization time Reduce the incidence of adverse events associated with analgesic therapy;Primary end point(s): determine if ropivacaine nebulization in CO2 used for abdominal inflation can reduce the postoperative pain connected with laparoscopic cholecystectomy | — |
Countries
Italy
Outcome results
None listed