Status:
TERMINATED
Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy
Lead Sponsor:
San Gerardo Hospital
Collaborating Sponsors:
University of Milano Bicocca
Azienda Ospedaliera di Lecco
Conditions:
Postoperative Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg produces better postoperative pain control than Saline nebulization after laparoscopic colectomy.
Detailed Description
Recently intraperitoneal nebulization of local anesthetic has been used as an alternative to direct intraperitoneal instillation. Intraperitoneal aerosolization of Bupivacaine 50 mg after laparoscopic...
Eligibility Criteria
Inclusion
- Females and Males 18-80 years old
- ASA Score I (American Society of Anesthesiologists classification : a normal healthy patient.
- ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease
- ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease
- Patients scheduled for oncological laparoscopic colectomy
- Patients who do not use opioids analgesic drugs before surgery
- Patients without cognitive impairment or mental retardation
Exclusion
- Females and Males under 18 or over 80
- ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life
- ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation
- Emergency/urgency surgery
- Postoperative admission in an intensive care unit with sedation or ventilatory assistance
- Cognitive impairment or mental retardation
- Use of opiods before surgery
- Progressive degenerative diseases of the CNS
- Convulsions or chronic therapy with antiepileptic drugs
- Severe hepatic or renal impairment
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01432496
Start Date
September 1 2011
End Date
December 1 2012
Last Update
February 25 2013
Active Locations (3)
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1
Azienda Ospedaliera di Lecco. Presidio "A.Manzoni"
Lecco, LC, Italy, 23900
2
San Gerardo Hospital
Monza, MB, Italy, 20052
3
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, Italy, 27100