Intravenous Lidocaine for Laparoscopic Cholecystectomy

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062906
• Other study ID #: GEN#08-021
• Status: Completed
• Phase: N/A
• First received: February 3, 2010
• Last updated: January 12, 2011
• Start date: March 2010
• Est. completion date: March 2010

Study information

• Verified date: February 2010
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Consumption
• Pain, Postoperative
• Postoperative Pain

Intervention

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)
• 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)

Locations

Country	Name	City	State
Canada	McGill University Health Centre, Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Lauwick S, Kim do J, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pain, Static and Dynamic		On postoperative day 0 (day of surgey before beeing discharged home) and 24 hrs after the end of surgery	Yes
Secondary	Opioids side-effects		On postoperative day 0 (before beeing discharged home) and at 24 hrs after the end of surgery	Yes