Lidocaine on Manifestations of Fibromyalgia (LIMAFIBRO)
|ClinicalTrials.gov Identifier: NCT00991848|
Recruitment Status : Completed
First Posted : October 8, 2009
Last Update Posted : October 9, 2009
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia Chronic Pain||Drug: Lidocaine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia|
|Study Start Date :||January 2005|
|Primary Completion Date :||July 2007|
|Study Completion Date :||September 2008|
Patients received 240 mg lidocaine diluted in 125 mL 0.9% saline. The solutions were infused over a period of 1 h, once a week, for 4 weeks (T1, T2, T3 and T4).
received 240 mg lidocaine diluted in 125 mL 0.9% saline.
- effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia [ Time Frame: 4 weeks ]
- Pain intensity by numerical scale (0 - 10)where 0 being an absent of pain and 10 measuring as the highest for pain intensity [ Time Frame: 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991848
|Federal University of São Paulo|
|São Paulo, Brazil|
|Study Chair:||Rioko K Sakata, PhD||Federal University of São Paulo|