Overview

Lidocaine on Pain Relief and IL and Substance P in Fibromyalgia

Status:
Unknown status
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
Summary
The study's primary objective is to evaluate the effect of intravenous lidocaine on pain and plasma interleukin-1 (IL-1), interleukin-6 (IL-6) and substance P in patients with fibromyalgia. As secondary objectives: evaluate the clinical manifestations, and plasma concentration of lidocaine.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Federal University of São Paulo
Treatments:
Acetaminophen
Amitriptyline
Amitriptyline, perphenazine drug combination
Analgesics
Lidocaine
Neurokinin A
Pharmaceutical Solutions
Polystyrene sulfonic acid
Substance P
Tramadol
Criteria
Inclusion Criteria:

- Patients with fibromyalgia will be included in the study through the classification
criteria proposed by the American College of Rheumatology (generalized
hypersensitivity and pain or stiffness in 11 of 18 musculotendinous insertions sites
for at least three months in the four quadrants of the body, absence of traumatic
injury, rheumatic disease, neuromuscular or infectious arthropathy).

Exclusion Criteria:

- Will be excluded from the study patients who had: no cognitive or language
comprehension; abnormal laboratory tests, trauma, psychiatric illness, rheumatic or
neuromuscular another pain syndrome, infectious arthropathy, hypersensitivity to drugs
and pregnant. Also will be excluded patients with arrhythmia, myocardial infarction,
concomitant use of cisapride or monoamine oxidase inhibitor, bundle branch block or
atrio-ventricular heart failure, acute, angle glaucoma, myasthenia gravis, severe
liver disease and hyperthyroidism; and those who are using centrally acting analgesic
medication (antidepressants, anticonvulsants, opioids, neuroleptics) for at least 4
weeks from baseline.

Patients who experience severe side effects related to the infusion of lidocaine (severe
hypotension and seizure) will be excluded from the study.