Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: San Gerardo Hospital
• Collaborators: Azienda Ospedaliera di Lecco; IRCCS Policlinico S. Matteo; University of Milano Bicocca; University of Pavia
• Treatments: Ropivacaine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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