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Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia
Background and Objectives: Fibromyalgia is a pain syndrome characterized by numerous manifestations. The objective of this study was to evaluate the effect of the combination of intravenous lidocaine and amitriptyline on the manifestations of fibromyalgia. Methods: A prospective, randomized, double-blind, comparative study was conducted. All patient received 25 mg amitriptyline. Patients of group 1 (n = 15) received 125 mL 0.9% saline, and patients of group 2 (n = 15) received 240 mg lidocaine in 125 mL 0.9% saline once a week for 4 weeks. Manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on a verbal numerical scale.
Amitriptyline was chosen in the present study because it is the most widely used antidepressant with proven analgesic efficacy for the treatment of a variety of chronic pain syndromes. Amitriptyline also promotes improvement of sleep, an effect observed in the present study. Lidocaine has been widely applied by the intravenous route and patients with a variety of pain syndromes, including fibromyalgia, have reported pain relief with this technique.The dose of lidocaine employed by various investigators ranges from 1 to 5 mg/kg administered over a period of 30-60 min. The minimum effective dose is 1.5 mL/L, which is achieved with 2-5 mg/kg infused over 30-60 min. In these study, 240 mg lidocaine was administered, corresponding to about 3 mg/kg.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
Federal University of São Paulo
São Paulo, São Paulo, Brazil
Start Date
January 1, 2005
Primary Completion Date
July 1, 2007
Completion Date
September 1, 2008
Last Updated
October 9, 2009
30
ACTUAL participants
Lidocaine
DRUG
Lead Sponsor
Federal University of São Paulo
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05901259