Intravenous Lidocaine for Laparoscopic Cholecystectomy

McGill University

Status: Completed

Conditions: Postoperative Pain; Opioid Consumption

Treatments: Drug: Lidocaine; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT01062906

GEN#08-021

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

The control group receives intravenous fentanyl at the induction of anesthesia followed by a continuous infusion of lidocaine during the surgery.

Treatment:

Drug: Fentanyl

Lidocaine

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine