Intravenous Lidocaine for Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Pain, Opioid Consumption

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>The control group receives intravenous fentanyl at the induction of anesthesia followed by a continuous infusion of lidocaine during the surgery. | Drug: Fentanyl<br>* 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)<br>|
| Active Comparator: Lidocaine<br>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<br>* 1.5 mg/Kg as bolus and a continuous infusion of 2mg/Kg/hr until the end of surgery (closure of the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fentanyl consumption (measured as fentanyl equivalents -mcg) |  | postoperative day 0 (day of surgery before beeing discharged home) and 24 hr after the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, Static and Dynamic |  | On postoperative day 0 (day of surgey before beeing discharged home) and 24 hrs after the end of surgery | 
| Opioids side-effects |  | On postoperative day 0 (before beeing discharged home) and at 24 hrs after the end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravenous lidocaine, postoperative pain, laparoscopic surgery, opioids, opioids side-effects