Intravenous Lidocaine for Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01062906
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : January 13, 2011
Information provided by:
McGill University Health Center

Brief Summary:

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
Postoperative Pain Opioid Consumption Drug: Lidocaine Drug: Fentanyl

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Intravenous Lidocaine on Short-term Outcomes After Laparoscopic Cholecystectomy
Study Start Date : March 2010
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Control
The control group receives intravenous fentanyl at the induction of anesthesia followed by a continuous infusion of lidocaine during the surgery.
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)
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
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)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Opioids side-effects [ Time Frame: On postoperative day 0 (before beeing discharged home) and at 24 hrs after the end of surgery ]

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01062906

Canada, Quebec
McGill University Health Centre, Montreal General Hospital
Montreal, Quebec, Canada, H3G1A4
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: Franco Carli, MD, professor McGill University Healt Centre, Department of Anesthesia

Responsible Party: Francesco Carli, McGill University Health Centre Identifier: NCT01062906     History of Changes
Other Study ID Numbers: GEN#08-021
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: January 13, 2011
Last Verified: February 2010

Keywords provided by McGill University Health Center:
intravenous lidocaine
postoperative pain
laparoscopic surgery
opioids side-effects

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General