Intravenous Lidocaine for Laparoscopic Cholecystectomy

NCT ID: NCT01062906

Last Updated: 2011-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-03-31

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.

Conditions

Postoperative Pain; Opioid Consumption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control

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

Group Type: PLACEBO_COMPARATOR

Fentanyl

Intervention Type: DRUG

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)

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

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

1.5 mg/Kg as bolus and a continuous infusion of 2mg/Kg/hr until the end of surgery (closure of the skin)

Interventions

Lidocaine

1.5 mg/Kg as bolus and a continuous infusion of 2mg/Kg/hr until the end of surgery (closure of the skin)

Intervention Type: DRUG

Fentanyl

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)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

McGill University Health Centre

Principal Investigators

Franco Carli, MD, professor

Role: PRINCIPAL_INVESTIGATOR

McGill University Healt Centre, Department of Anesthesia

Locations

McGill University Health Centre, Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

References

Lauwick S, Kim DJ, 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. doi: 10.1007/BF03016348.

Reference Type: BACKGROUND

PMID: 19138915 (View on PubMed)

Other Identifiers

GEN#08-021

Identifier Type: -

Identifier Source: org_study_id