Intravenous Lidocaine for Laparoscopic Cholecystectomy

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)

Overall Status

Completed

CT.gov ID

NCT01062906

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Opioid Consumption	Drug: Lidocaine Drug: Fentanyl	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: Control

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

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)

Active Comparator: 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

Drug: Lidocaine

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.