Postoperative Pain Clinical Trial
Official title:
The Effect of Intravenous Lidocaine on Short-term Outcomes After Laparoscopic Cholecystectomy
Verified date | February 2010 |
Source | McGill University Health Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Centre, Montreal General Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Center |
Canada,
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
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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