Intravenous Lidocaine for Laparoscopic Cholecystectomy
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|ClinicalTrials.gov Identifier: NCT01062906|
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : January 13, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Opioid Consumption||Drug: Lidocaine Drug: Fentanyl||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Intravenous Lidocaine on Short-term Outcomes After Laparoscopic Cholecystectomy|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
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)
- 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 ]
- 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 ]
- Opioids side-effects [ Time Frame: On postoperative day 0 (before beeing discharged home) and at 24 hrs after the end of surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062906
|McGill University Health Centre, Montreal General Hospital|
|Montreal, Quebec, Canada, H3G1A4|
|Principal Investigator:||Franco Carli, MD, professor||McGill University Healt Centre, Department of Anesthesia|