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
  Purpose

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)

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062906

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

Publications:
Responsible Party: Francesco Carli, McGill University Health Centre
ClinicalTrials.gov 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
opioids side-effects

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Fentanyl
Lidocaine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 23, 2014