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

Neuropathic Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Neuropathic Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:LidocaineLidocaine 5 mg/kg in 250 ml of normal saline infused over 45 minutes.

Drug:DiphenhydramineDiphenhydramine 50 mg in 250 ml of normal saline infused over 45 minutes.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Diphenhydramine(Benadryl)

Lidocaine

Study Status

Completed

Start Date: September 2011

Completed Date: December 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Changes from Baseline Pain scores on the Visual Analog Scale at 6 weeks

Secondary Outcome: Hospital Anxiety and Depression Scale

Study sponsors, principal investigator, and references

Principal Investigator: Dwight Moulin, Dr.

Lead Sponsor: Lawson Health Research Institute

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01669967

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