Skip to main content
OpenTrials
Completed

NCT Number: NCT00991848

Lidocaine on Manifestations of Fibromyalgia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia Chronic Pain Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Federal University of São Paulo

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

received 240 mg lidocaine diluted in 125 mL 0.9% saline.

Primary outcomes

  1. effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia

    Time frame: 4 weeks

Secondary outcomes

  1. Pain intensity by numerical scale (0 - 10)where 0 being an absent of pain and 10 measuring as the highest for pain intensity

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia

Acronym: LIMAFIBRO

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Oct 8, 2009
Registry last updated
Oct 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.