Lidocaine on Manifestations of Fibromyalgia (LIMAFIBRO)

Federal University of São Paulo

Status and phase: Completed; Phase 1

Conditions: Fibromyalgia; Chronic Pain

Treatments: Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00991848

NSA

MAF09

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pain in the four quadrants of the body for at least 3 months
• sleep disorders
• fatigue
• subjective edema
• depression
• paresthesia.

Exclusion criteria

• alterations in thyroid
• rheumatological
• renal and hepatic function
• trauma
• rheumatic, neuromuscular or psychiatric disease
• infectious arthropathy
• other pain syndromes
• drug hypersensitivity
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 1 patient group

Lidocaine

Experimental group

Description:

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).

Treatment:

Drug: Lidocaine