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Intravenous Lidocaine for Laparoscopic Cholecystectomy

Information source: McGill University Health Center
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Pain; Opioid Consumption

Intervention: Lidocaine (Drug); Fentanyl (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: McGill University Health Center

Official(s) and/or principal investigator(s):
Franco Carli, MD, professor, Principal Investigator, Affiliation: McGill University Healt Centre, Department of Anesthesia

Overall contact:
Francesco Carli, MD, Professor, Email: franco.carli@mcgill.ca

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.

Clinical Details

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

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

Primary outcome: Fentanyl consumption (measured as fentanyl equivalents -mcg)

Secondary outcome:

Pain, Static and Dynamic

Opioids side-effects

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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.

Locations and Contacts

Francesco Carli, MD, Professor, Email: franco.carli@mcgill.ca

McGill University Health Centre, Montreal General Hospital, Montreal, Quebec H3G1A4, Canada; Recruiting
Francesco Carli, MD, professor, Email: franco.carli@mcgill.ca
Gabriele Baldini, MD, Email: gabriele.baldini@mail.mcgill.ca
Gabriele Baldini, MD, Principal Investigator
Francesco Carli, MD, Principal Investigator
Additional Information

Related 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.

Starting date: September 2009
Last updated: February 3, 2010

Page last updated: October 04, 2010

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