Intravenous Lidocaine for Laparoscopic Cholecystectomy
Intravenous lidocaine has been shown to have analgesic, antinflammatory, antihyperalgesic, antithrombotics and neuroprotective properties. In a previous study conducted in patients undergoing laparoscopic cholecystectomy under general anesthesia with desflurane and fentanyl, intraoperative i.v. infusion of lidocaine spared opioids consumption in the recovery room by 30%.
The purpose of this study was to determine if an i.v. infusion of lidocaine without intraoperative opioids would reduce the amount of fentanyl to the same extent and opioids-related side effects.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Intravenous Lidocaine on Short-term Outcomes After Laparoscopic Cholecystectomy|
- Fentanyl consumption (measured as fentanyl equivalents -mcg) [ Time Frame: postoperative day 0 (day of surgery before beeing discharged home) and 24 hr after the end of surgery ] [ Designated as safety issue: Yes ]
- Pain, Static and Dynamic [ Time Frame: On postoperative day 0 (day of surgey before beeing discharged home) and 24 hrs after the end of surgery ] [ Designated as safety issue: Yes ]
- Opioids side-effects [ Time Frame: On postoperative day 0 (before beeing discharged home) and at 24 hrs after the end of surgery ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2010|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: Control
The control group receives intravenous fentanyl at the induction of anesthesia followed by a continuous infusion of lidocaine during the surgery.
Fentanyl 3 mcg/Kg as bolus at the induction and a continuous infusion of normal saline (NaCl 0.9%) until the end of surgery (skin closure)
Active Comparator: Lidocaine
The Lidocaine group will receive lidocaine as bolus at the induction of anesthesia followed by a continuous infusion of lidocaine until the end of surgery
1.5 mg/Kg as bolus and a continuous infusion of 2mg/Kg/hr until the end of surgery (closure of the skin)
|McGill University Health Centre, Montreal General Hospital|
|Montreal, Quebec, Canada, H3G1A4|
|Principal Investigator:||Franco Carli, MD, professor||McGill University Healt Centre, Department of Anesthesia|