Status:
COMPLETED
Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery
Lead Sponsor:
San Gerardo Hospital
Collaborating Sponsors:
University of Milano Bicocca
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Laparoscopic Cholecystectomy
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 50 mg, 100 mg or 150 mg may prevent the use of morphine during the first day after laparoscopic cholecystectomy.
Detailed Description
Intraperitoneal aerosolization of Bupivacaine 50 mg after laparoscopic cholecystectomy has been proved to significantly reduce postoperative pain, morphine consumption and incidence of postoperative n...
Eligibility Criteria
Inclusion
- Females and Males 18-75 years old
- ASA Score I-III
- Scheduled for laparoscopic cholecystectomy
- Free from pain in preoperative period
- Not using analgesic drugs before surgery
- Without cognitive impairment or mental retardation
- Written informed consent
Exclusion
- Emergency/urgency surgery
- Postoperative admission in an intensive care unit
- Cognitive impairment or mental retardation
- Progressive degenerative diseases of the CNS
- Seizures 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT01143025
Start Date
March 1 2010
End Date
May 1 2011
Last Update
May 19 2011
Active Locations (1)
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1
San Gerardo Hospital
Monza, MB, Italy, 20052