Impact of intraperitonael nebulization of local anesthetic on postoperative pain associated with laparoscopic cholecystectomy - ND

• Conditions: Intra and post operatorive period; MedDRA version: 9.1Level: SOCClassification code 10019805Term: Hepatobiliary disorders

• Registration Number: EUCTR2008-002029-36-IT
• Lead Sponsor: A.O. SAN GERARDO DI MONZA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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:<br>Reduce anesthetic and analgesic consumption during surgery<br>Reduce the central temperature loss during surgery<br>Reduce the analgesic consumption after surgery <br>Return earlier to walking after surgery <br>Reduce hospitalization time <br>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