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Completed

NCT Number: NCT01669967

The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin

Pain as a result of nerve injury (neuropathic pain) is a particularly severe form of chronic pain. Common examples of neuropathic pain are pain due to diabetes and shingles. There is good evidence that an intravenous infusion of lidocaine (local anesthetic) is useful for the management of neuropathic pain in the short term - up to six hours.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

About this study

This study will examine the role of intravenous lidocaine in the relief of neuropathic pain over four weeks following infusion compared to an active placebo infusion of diphenhydramine(Benadryl) in normal saline. If we can show that intravenous lidocaine provides sustained benefit for up to one month, this will be a major advance in the management of individuals suffering from neuropathic pain.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic neuropathic pain due to diabetes mellitus or herpes zoster and a score of 4/10 or greater on the DN4 questionnaire.
  • Moderate to severe pain as defined by screening average pain intensity of 5 or greater on a 0-10 numerical rating scale.
  • Neuropathic pain duration of at least 6 months.

Exclusion criteria

  • Presence of clinically significant cardiac disease.
  • Poorly controlled seizure disorder.
  • Significant psychiatric disorder.
  • History of allergy to lidocaine or any other amide local anesthetic
  • History of allergy to diphenhydramine.
  • Prior treatment with a local anesthetic infusion.
  • Neuropathic pain due to cancer or complex regional pain syndrome
  • Language barrier or cognitive impairment that would preclude understanding of the study and filling out of questionnaires
  • Lack of a driver to transport the patient to and from the pain clinic.

Treatment and study plan

Lidocaine

Drug

Lidocaine 5 mg/kg in 250 ml of normal saline infused over 45 minutes.

Other names: Xylocaine

diphenhydramine

Drug

Diphenhydramine 50 mg in 250 ml of normal saline infused over 45 minutes.

Other names: Benadryl

Primary outcomes

  1. Changes from Baseline Pain scores on the Visual Analog Scale at 4 weeks

    Time frame: every 24 hours for four weeks post-infusion

Secondary outcomes

  1. Hospital Anxiety and Depression Scale

    Time frame: obtained baseline, 24 and 72 hours and then weeks 1,2,3, and 4

  2. Modified Brief Pain Inventory

    Time frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4

  3. Leeds Sleep Evaluation Questionnaire

    Time frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4

  4. Patient Global Satisfaction with Treatment and Impression of Change

    Time frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4

  5. Side Effects

    Time frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4

  6. Quality of Life Health Outcome Instrument

    Time frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 21, 2012
Registry last updated
Mar 15, 2019

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.

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