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Intravenous Lidocaine for Fibromyalgia

Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00986505
Enrollment
30
Registered
2009-09-30
Start date
2005-02-28
Completion date
2007-12-31
Last updated
2009-09-30

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

Conditions

Fibromyalgia

Keywords

lidocaine, fibromyalgia, intravenous lidocaine, manifestations

Brief summary

The effect of intravenous lidocaine infusion on manifestations of fibromyalgia manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on a numerical scale.The combination of 240 mg intravenous lidocaine (once a week) and 25 mg amitriptyline for 4 weeks did not modify pain intensity or manifestations in patients with fibromyalgia.

Detailed description

Thirty patients ranging in age from 18 to 60 years, with fibromyalgia (American College of Rheumatology criteria: pain in the four quadrants of the body for at least 3 months and a minimum of 11 out of 18 tender points) were studied. Other manifestations were also recorded: sleep disorders, fatigue, subjective edema, depression, and paresthesia. Criteria for exclusion were alterations in thyroid, rheumatological, renal and hepatic function; trauma; rheumatic, neuromuscular or psychiatric disease; infectious arthropathy; other pain syndromes; drug hypersensitivity, and pregnancy. All patients received amitriptyline at a dose of 12.5 mg in the first week and 25 mg over the subsequent 4 weeks. Patients of group 1 (n = 15) received 125 mL 0.9% saline and patients of group 2 (n = 15) 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).

Interventions

DRUGLidocaine

Intravenous lidocaine once a week

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

* 18 to 60 years, with fibromyalgia (American College of Rheumatology criteria: pain in the four quadrants of the body for at least 3 months and a minimum of 11 out of 18 tender points

Exclusion criteria

* Thyroid, rheumatological, renal and hepatic function * Trauma * Rheumatic, neuromuscular or psychiatric disease * Infectious arthropathy * Other pain syndromes * Drug hypersensitivity; AND * Pregnancy

Design outcomes

Primary

MeasureTime frame
pain1day

Secondary

MeasureTime frame
other signs1day

Outcome results

None listed

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