Effectiveness and Safety of Lidocaine for Scleroderma

• Safety - evaluated by the adverse effects during the intervention [ Time Frame: immediately after the intervention ] [ Designated as safety issue: Yes ]
• Quality of Life evaluated by HAQ [ Time Frame: before, immediately after the intervention and 6 months later ] [ Designated as safety issue: No ]
• Pressure at lower esophagus evaluated by esophagus manometry [ Time Frame: before, immediately after the intervention and 6 months later ] [ Designated as safety issue: No ]
• Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy [ Time Frame: before, immediately after the intervention and 6 months later ] [ Designated as safety issue: No ]
• Subjective evaluation by patients [ Time Frame: before, immediately after the intervention and 6 months later ] [ Designated as safety issue: No ]

Scleroderma, or systemic sclerosis, is a chronic connective tissue disease generally classified as one of the autoimmune rheumatic diseases. The disease is characterized by thickening and fibrosis skin, affecting vessels and many organs such as the esophagus, stomach, bowls, lung, heart and kidney. The exact cause or causes of scleroderma are still unknown, but scientists and medical investigators in a wide variety of fields are working hard to make those determinations. It is known that scleroderma involves overproduction of collagen.

FLICKMAN et al, in 1973 published an article about the role of lidocaine at prolyl-hydroxylase activity decrease, which is an important enzyme of collagen production. Until now, there is only a case series showing the improvement of thickening skin (75%) and esophagus symptoms (66%) after intravenous lidocaine 2% during 10 days. So it is necessary a RCT to prove these findings.

• Drug: Lidocaine 2% without vessel constrictor
  • first 5 days: 20ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours
  • next 5 days: 30ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours total: 10 days
• Other: Placebo - physiological solution 0,9%
  first 5 days: 20ml of physiological solution 0,9% 500ml + physiological solution 0,9% 500ml intravenously during 4 hours next 5 days: 30ml of physiological solution 0,9% 500ml + physiological solution 0,9% 500ml intravenously during 4 hours total: 10 days

• Experimental: 1
  Intervention: Drug: Lidocaine 2% without vessel constrictor
• Placebo Comparator: 2
  Intervention: Other: Placebo - physiological solution 0,9%

Inclusion Criteria:

• Scleroderma (diffuse or limited) at less than 5 years of the first symptom

Exclusion Criteria:

• Overlap with other connective tissue diseases
• Fibromyalgia
• Pregnancy
• Current use of ciclofosfamide ou D-penicillamine