Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Postoperative Pain |
Intervention | Drug: Ropivacaine 150 mg Drug: saline 15 ml |
Phase | Phase 3 |
Sponsor | San Gerardo Hospital |
Responsible Party | San Gerardo Hospital |
ClinicalTrials.gov Identifier | NCT01432496 |
First Received | September 9, 2011 |
Last Updated | February 22, 2013 |
Last verified | February 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | September 9, 2011 |
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Last Updated Date | February 22, 2013 |
Start Date | September 2011 |
Estimated Primary Completion Date | December 2012 |
Current Primary Outcome Measures | Postoperative pain [Time Frame: 72 hours] [Designated as safety issue: No]Numeric Ranking Scale (NRS 0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS) in PACU and at 6, 24, 48 and 72 hours after the discharge from PACU. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy |
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Official Title | A Multicentric, Randomized, Controlled, Double Blinded, Phase III Clinical Trial; Comparing Peritoneal Nebulization of Ropivacaine 150 mg With Peritoneal Nebulization of Saline |
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 cholecystectomy significantly reduced postoperative pain, morphine consumption and incidence of postoperative nausea and vomiting and it is associated with rapid mobilization compared with patients receiving direct instillation of Bupivacaine 50 mg or placebo. In a recent study the investigators found that nebulization of Ropivacaine 30 mg with the AeronebPro® before or after laparoscopic cholecystectomy and gynecologic laparoscopic surgery reduces postoperative pain and morphine consumption. Patients receiving preoperative nebulization of Ropivacaine presented significantly less postoperative pain (-50% clinical setting) and consumed significant less morphine (-50% and -40% respectively) than patients in control groups during the first 48 hours after surgery. The effects of peritoneal nebulization of ropivacaine during laparoscopic colectomy on pain control and morphine consumption were not evaluated. The investigators hypothesize that intraperitoneal nebulization of Ropivacaine may produce better pain control and less morphine consumption than nebulization of saline after laparoscopic colectomy. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Postoperative Pain |
Intervention | Drug: Ropivacaine 150 mg Nebulization of Ropivacaine 150 mg in the peritoneal cavity Other Names: Nebulization RopivacaineDrug: saline 15 ml Nebulization of saline 15 ml in the peritoneal cavity Other Names: Nebulization Saline |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
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Estimated Enrollment | 130 |
Estimated Completion Date | December 2012 |
Estimated Primary Completion Date | December 2012 |
Eligibility 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Italy |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01432496 |
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Other Study ID Numbers | AR HSG 06 2010 Colectomy |
Has Data Monitoring Committee | No |
Information Provided By | San Gerardo Hospital |
Study Sponsor | San Gerardo Hospital |
Collaborators | University of Milano Bicocca Azienda Ospedaliera di Lecco IRCCS Policlinico S. Matteo University of Pavia |
Investigators | Principal Investigator: Pablo M Ingelmo, MD San Gerardo Hospital, MB, Italy |
Verification Date | February 2013 |
Locations[ + expand ][ + ]
Azienda Ospedaliera di Lecco. Presidio "A.Manzoni" | Lecco, LC, Italy, 23900 |
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San Gerardo Hospital | Monza, MB, Italy, 20052 |
Fondazione IRCCS Policlinico San Matteo | Pavia, PV, Italy, 27100 |