Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multicentric, Randomized, Controlled, Double Blinded, Phase III Clinical Trial; Comparing Peritoneal Nebulization of Ropivacaine 150 mg With Peritoneal Nebulization of Saline|
- 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.
- 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
|Study Start Date:||September 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Ropivacaine 150 mg
Nebulization of Ropivacaine 150 mg in the peritoneal cavity with the Aeroneb Pro system
Drug: Ropivacaine 150 mg
Nebulization of Ropivacaine 150 mg in the peritoneal cavity
Other Name: Nebulization Ropivacaine
Placebo Comparator: Saline 15 ml
Nebulization of Saline 15 ml in the peritoneal cavity with the Aeroneb Pro system
Drug: saline 15 ml
Nebulization of saline 15 ml in the peritoneal cavity
Other Name: Nebulization Saline
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432496
|Azienda Ospedaliera di Lecco. Presidio "A.Manzoni"|
|Lecco, LC, Italy, 23900|
|San Gerardo Hospital|
|Monza, MB, Italy, 20052|
|Fondazione IRCCS Policlinico San Matteo|
|Pavia, PV, Italy, 27100|
|Principal Investigator:||Pablo M Ingelmo, MD||San Gerardo Hospital, MB, Italy|