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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 3, 2010

Last Updated Date

January 12, 2011

Start Date ^ICMJE

March 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01062906 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intravenous Lidocaine for Laparoscopic Cholecystectomy

Official Title ^ICMJE

The Effect of Intravenous Lidocaine on Short-term Outcomes After Laparoscopic Cholecystectomy

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Postoperative Pain
Opioid Consumption

Intervention ^ICMJE

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)

Study Arm (s)

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

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

March 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01062906

Other Study ID Numbers ^ICMJE

GEN#08-021

Has Data Monitoring Committee

Yes

Responsible Party

Francesco Carli, McGill University Health Centre

Study Sponsor ^ICMJE

McGill University Health Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Franco Carli, MD, professor

McGill University Healt Centre, Department of Anesthesia

Information Provided By

McGill University Health Center

Verification Date

February 2010

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

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