Intravenous Lidocaine for Laparoscopic Cholecystectomy

January 12, 2011 updated by: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G1A4
        • McGill University Health Centre, Montreal General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
postoperative day 0 (day of surgery before beeing discharged home) and 24 hr after the end of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
On postoperative day 0 (before beeing discharged home) and at 24 hrs after the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: Franco Carli, MD, professor, McGill University Healt Centre, Department of Anesthesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

February 3, 2010

First Submitted That Met QC Criteria

February 3, 2010

First Posted (Estimate)

February 4, 2010

Study Record Updates

Last Update Posted (Estimate)

January 13, 2011

Last Update Submitted That Met QC Criteria

January 12, 2011

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEN#08-021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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