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 DynamicOpioids 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
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