Lidocaine on Manifestations of Fibromyalgia

Chronic Pain Clinical Trial

— LIMAFIBRO  

Official title:

Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991848
• Other study ID #: MAF09
• Secondary ID: NSA
• Status: Completed
• Phase: Phase 1
• First received: October 6, 2009
• Last updated: October 8, 2009
• Start date: January 2005
• Est. completion date: September 2008

Study information

• Verified date: October 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Background and Objectives: Fibromyalgia is a pain syndrome characterized by numerous manifestations. The objective of this study was to evaluate the effect of the combination of intravenous lidocaine and amitriptyline on the manifestations of fibromyalgia. Methods: A prospective, randomized, double-blind, comparative study was conducted. All patient received 25 mg amitriptyline. Patients of group 1 (n = 15) received 125 mL 0.9% saline, and patients of group 2 (n = 15) received 240 mg lidocaine in 125 mL 0.9% saline once a week for 4 weeks. Manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on a verbal numerical scale.

Description:

Amitriptyline was chosen in the present study because it is the most widely used antidepressant with proven analgesic efficacy for the treatment of a variety of chronic pain syndromes. Amitriptyline also promotes improvement of sleep, an effect observed in the present study.

Lidocaine has been widely applied by the intravenous route and patients with a variety of pain syndromes, including fibromyalgia, have reported pain relief with this technique.The dose of lidocaine employed by various investigators ranges from 1 to 5 mg/kg administered over a period of 30-60 min. The minimum effective dose is 1.5 mL/L, which is achieved with 2-5 mg/kg infused over 30-60 min. In these study, 240 mg lidocaine was administered, corresponding to about 3 mg/kg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• pain in the four quadrants of the body for at least 3 months

• sleep disorders

• fatigue

• subjective edema

• depression

• paresthesia.

Exclusion Criteria:

• alterations in thyroid

• rheumatological

• renal and hepatic function

• trauma

• rheumatic, neuromuscular or psychiatric disease

• infectious arthropathy

• other pain syndromes

• drug hypersensitivity

• pregnancy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Lidocaine
received 240 mg lidocaine diluted in 125 mL 0.9% saline.

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia		4 weeks	Yes
Secondary	Pain intensity by numerical scale (0 - 10)where 0 being an absent of pain and 10 measuring as the highest for pain intensity		4 weeks	Yes