Intravenous Lidocaine for Laparoscopic Cholecystectomy

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

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 Intervention
Postoperative Pain
Opioid Consumption
Drug: Lidocaine
Drug: Fentanyl

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: March 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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.
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Francesco Carli, McGill University Health Centre Identifier: NCT01062906     History of Changes
Other Study ID Numbers: GEN#08-021 
Study First Received: February 3, 2010
Last Updated: January 12, 2011
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Pain, Postoperative
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Adjuvants, Anesthesia
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Anti-Arrhythmia Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Voltage-Gated Sodium Channel Blockers processed this record on May 26, 2016