Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy | RxWiki

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.
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
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	Time of unassisted walking [Time Frame: 72 hours] [Designated as safety issue: No]Unassisted walking time is defined as the time in hours between PACU discharge and when the patient is able to walk out of his room and back to bed without any assistance. Return to active bowel function [Time Frame: 72 hours] [Designated as safety issue: No]The return of bowel function will be assessed using two parameters: time of first flatus and time of first bowel movement. Hospital morbidity [Time Frame: 72 hours] [Designated as safety issue: Yes]All complications or adverse effects associated or possibly associated with the interventions under study, surgery or anesthesia will be quantified Time and condition for hospital discharge [Time Frame: 72 hours] [Designated as safety issue: No]Time in days elapsed between surgery and hospital discharge. Analgesic consumption [Time Frame: 72 hours] [Designated as safety issue: No]The total dose of morphine will be quantified using the PACU clinical chart and/or PCA infusers memory display

Descriptive Information[ + expand ][ + ]

Brief Title	Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy
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)	Experimental: Ropivacaine 150 mg Nebulization of Ropivacaine 150 mg in the peritoneal cavity with the Aeroneb Pro system Placebo Comparator: Saline 15 ml Nebulization of Saline 15 ml in the peritoneal cavity with the Aeroneb Pro system

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
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
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 ][ + ]