Intravenous Lidocaine for Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01062906
First received: February 3, 2010
Last updated: January 12, 2011
Last verified: February 2010

February 3, 2010
January 12, 2011
March 2010
March 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01062906 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Intravenous Lidocaine for Laparoscopic Cholecystectomy
The Effect of Intravenous Lidocaine on Short-term Outcomes After 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Postoperative Pain
  • Opioid Consumption
  • Drug: Lidocaine
    1.5 mg/Kg as bolus and a continuous infusion of 2mg/Kg/hr until the end of surgery (closure of the skin)
  • Drug: Fentanyl
    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)
  • Placebo Comparator: Control
    The control group receives intravenous fentanyl at the induction of anesthesia followed by a continuous infusion of lidocaine during the surgery.
    Intervention: Drug: Fentanyl
  • 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
    Intervention: Drug: Lidocaine
Lauwick S, Kim do J, Michelagnoli G, Mistraletti G, Feldman L, Fried G, Carli F. Intraoperative infusion of lidocaine reduces postoperative fentanyl requirements in patients undergoing laparoscopic cholecystectomy. Can J Anaesth. 2008 Nov;55(11):754-60.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients undergoing laparoscopic cholecystectomy

Exclusion Criteria:

  • age <18 yr or > 85 yr,
  • ASA physical status 3 and greater, history of hepatic failure (Child & Pug A-C),
  • renal failure (creatinine outside the normal range) or cardiac failure (NYHA I-IV),
  • Adams-Stoke syndrome,
  • severe degrees of sinoatrial, atrioventricular or intraventricular block,
  • organ transplant,
  • diabetes mellitus type 1 and 2,
  • morbid obesity (BMI > 40),
  • chronic use of opioids and beta-blockers,
  • known seizures,
  • severe mental impairment,
  • allergy to local anesthetics and to all the medications used in the study, or
  • inability to understand pain assessment.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01062906
GEN#08-021
Yes
Francesco Carli, McGill University Health Centre
McGill University Health Center
Not Provided
Principal Investigator: Franco Carli, MD, professor McGill University Healt Centre, Department of Anesthesia
McGill University Health Center
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP