Lidocaine on Pain Relief and IL and Substance P in Fibromyalgia
Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibromyalgia
Intervention: Lidocaine (Drug); lidocaine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Federal University of São Paulo Overall contact: Ana Laura A Giraldes, Md, Phone: 50847463, Ext: 55, Email: analgiraldes@hotmail.com
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.
Clinical Details
Official title: Evaluation of the Effect of Intravenous Lidocaine on Pain Relief and Plasma Concentrations of Interleukins (IL-1 and IL-6) and Substance P in Patients With Fibromyalgia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Evaluation of the effect of intravenous lidocaine on pain relief and plasma concentrations of interleukins (IL-1 and IL-6) and substance P in patients with fibromyalgia
Detailed description:
Fibromyalgia is a painful syndrome characterized by chronic diffuse pain and involvement of
multiple muscles and soft tissues 1. The pain is very common, with prevalence around 2% in
the adult population.
In fibromyalgia, there is an increase of both somatic and visceral nociception, and
dysfunction of central nervous. system According to the American College of Rheumathology
diagnostic criteria for fibromyalgia are widespread pain and the presence of 11 of 18
typical tender points 3.
Minor criteria in the inclusion of patients for the diagnosis of fibromyalgia, such as pain
that changes with physical activity, sleep disturbance, fatigue, anxiety, depression,
paresthesia, cramps, sensation of swelling 4. Several co-morbidities may be associated with
pain such as migraine, myofascial pain syndrome, and irritable bowel syndrome.
The symmetry of these conditions shows that fibromyalgia is associated with central
sensitization 5. The pathophysiological mechanisms of fibromyalgia are related to changes in
neurotransmitters 6,7,8. Cytokines may be involved in modulation of symptoms such as
hyperalgesia, fatigue and depression, and maintenance of sympathetic pain 9.
] The substance P ( SP ) levels are increased in cerebrospinal fluid of patients with
fibromyalgia compared to control groups 10.
Antidepressants are the most widely used drugs for its treatment. The drug most commonly
used is amitriptyline.
Other drugs (muscle relaxants, anticonvulsants, NSAIDs, tramadol) are also employed.
Physical activity is essential to control the symptoms. Physical measures, psychotherapy,
occupational therapy are other treatments, but the effectiveness is variable 14. 15.
Sometimes a combination of drugs and techniques are needed to obtain satisfactory results.
The infusion of local anesthetic is given intravenously for fibromyalgia when oral
medication does not produce the proper effect. It promotes sympathetic blockade,
vasodilation, anesthesia of the nerve endings in the vascular endothelium, stabilization of
membrane and breaks the vicious circle that keeps pain 16.
Local anesthetics are membrane-stabilizing and prevent the generation of ectopic impulses in
lower concentrations than those needed to block the normal driving. The dose used by
different authors ranged from 1 to 5 mg / kg, administered in 30-60 minutes 17-24. Side
effects of lidocaine are: sedation, vertigo, dizziness, blurred vision, nausea and vomiting
25.
The effectiveness of intravenous lidocaine in neuropathic pain is well established 26.
Despite evidence of analgesic effect, there is controversy in conditions without nerve
injury. It may be that the selectivity of the effect for non-neuropathic and neuropathic
pain is relative and depends on the plasma concentration reached25.
For the use of systemic lidocaine in fibromyalgia, there are no well-controlled studies, and
to assess changes of cytokines and substance P, which stimulated this research.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Ana Laura A Giraldes, Md, Phone: 50847463, Ext: 55, Email: analgiraldes@hotmail.com
Federal Unifesrity of Sao Paulo, Sao Paulo, Brazil; Recruiting Ana Laura A Giraldes, Md, Phone: 50847463, Ext: 55(11), Email: analgiraldes@hotmail.com
Additional Information
Starting date: January 2010
Last updated: July 11, 2011
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