Impact of intraperitonael nebulization of local anesthetic on hypothermia and postoperative pain associated with laparoscopic surgery - ND

• Conditions: Intra and post operatorive period; MedDRA version: 9.1Level: SOCClassification code 10038604Term: Reproductive system and breast disorders

• Registration Number: EUCTR2008-002030-30-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: Female
• 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

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 drop of central temperature connected with operative gynecologic laparoscopy.;Secondary Objective: The secondary endpoint of the study is to determine if preoperative and/or postoperative ropivacaine nebulization in patients undergoing laparoscopic surgery is more effective than preoperative direct instillation in peritoneum in order to: Reduce postoperative pain in the first 48 hours after surgery Reduce postoperative analgesic consumption 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 drop of central temperature connected with operative gynecologic laparoscopy