Intravenous Lidocaine for Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Postoperative Pain; Opioid Consumption
• Interventions: Drug: Fentanyl; Drug: Lidocaine

• Registration Number: NCT01062906
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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 available

Study Timeline

• Status Verified: 2010-02
• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Study Start: 2010-03
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2011-01-12
• Last Update Posted: 2011-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Fentanyl	The control group receives intravenous fentanyl at the induction of anesthesia followed by a continuous infusion of lidocaine during the surgery.
Lidocaine	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

McGill University Health Centre, Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada