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Intravenous Lidocaine for Fibromyalgia

F

Federal University of São Paulo

Status

Completed

Conditions

Fibromyalgia

Treatments

Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT00986505
IV lidocaine

Details and patient eligibility

About

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.

Full 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).

Enrollment

30 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 1 patient group

Lidocaine
Experimental group
Description:
Comparison between intravenous lidocaine and saline infusion
Treatment:
Drug: Lidocaine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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