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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01062906
Other study ID # GEN#08-021
Secondary ID
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


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
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