Lidocaine on Pain Relief and IL and Substance P in Fibromyalgia

NCT01391598 | Unknown Phase 3 DMC

• 1 other identifier: FibromialgiaGiraldes
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; intravenous lidocaine; substance P; interleukins

Outcome Measures

Primary Outcomes (1)

• 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

  60 days

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

After completion of the inclusion criteria all patients receive a dose of amitriptyline 12.5 mg in the first week, and 25 mg in the eight subsequent weeks, orally, once daily at night. At lidocaine group 20 pacients will receive lidocaine at a dose of 4 mg / kg, not exceeding a dose of 240 mg diluted in 125ml of solution 0.9% saline.The solutions will be infused in 1 hour once a week in the four weeks following the start of the study..:Patients may use as additional analgesics up to 4g/day acetaminophen, and if necessary, they can use tramadol, recording the dose

Drug: Lidocaine

Saline

PLACEBO COMPARATOR

After completion of the inclusion criteria all patients receive a dose of amitriptyline 12.5 mg in the first week, and 25 mg in the eight subsequent weeks, orally, once daily at night. At saline group 20 pacients will receive 125ml of solution 0.9% saline.The solutions will be infused in 1 hour once a week in the four weeks following the start of the study. Patients may use as additional analgesics up to 4g/day acetaminophen, and if necessary, they can use tramadol, recording the dose

Drug: lidocaine

Interventions

lidocaine DRUG

After completion of the inclusion criteria all patients receive a dose of amitriptyline 12.5 mg in the first week, and 25 mg in the eight subsequent weeks, orally, once daily at night. At lidocaine group 20 pacients will receive lidocaine at a dose of 4 mg / kg, not exceeding a dose of 240 mg diluted in 125ml of solution 0.9% saline.The solutions will be infused in 1 hour once a week in the four weeks following the start of the study..:Patients may use as additional analgesics up to 4g/day acetaminophen, and if necessary, they can use tramadol, recording the dose

Lidocaine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal Unifesrity of Sao Paulo

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Ana Laura A Giraldes, Md

CONTACT

50847463; analgiraldes@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 12, 2011
• Study Start: January 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 12, 2011

Record last verified: 2009-12

Locations

BR (1)