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Lidocaine on Manifestations of Fibromyalgia

Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00991848
Acronym
LIMAFIBRO
Enrollment
30
Registered
2009-10-08
Start date
2005-01-31
Completion date
2008-09-30
Last updated
2009-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Fibromyalgia

Keywords

Lidocaine;, Fibromyalgia, signs, symptoms

Brief summary

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.

Detailed 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.

Interventions

DRUGLidocaine

received 240 mg lidocaine diluted in 125 mL 0.9% saline.

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia4 weeks

Secondary

MeasureTime frame
Pain intensity by numerical scale (0 - 10)where 0 being an absent of pain and 10 measuring as the highest for pain intensity4 weeks

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026