The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
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ClinicalTrials.gov Identifier: NCT01669967 |
Recruitment Status :
Completed
First Posted : August 21, 2012
Last Update Posted : March 15, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuropathic Pain | Drug: Lidocaine Drug: Diphenhydramine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Other |
Official Title: | The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Diphenhydramine(Benadryl) |
Drug: Diphenhydramine
Diphenhydramine 50 mg in 250 ml of normal saline infused over 45 minutes.
Other Name: Benadryl |
Active Comparator: Lidocaine |
Drug: Lidocaine
Lidocaine 5 mg/kg in 250 ml of normal saline infused over 45 minutes.
Other Name: Xylocaine |
- Changes from Baseline Pain scores on the Visual Analog Scale at 4 weeks [ Time Frame: every 24 hours for four weeks post-infusion ]
- Hospital Anxiety and Depression Scale [ Time Frame: obtained baseline, 24 and 72 hours and then weeks 1,2,3, and 4 ]
- Modified Brief Pain Inventory [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ]
- Leeds Sleep Evaluation Questionnaire [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 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 ]
- Side Effects [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ]
- Quality of Life Health Outcome Instrument [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669967
Canada, Ontario | |
St. Joseph's Health Care | |
London, Ontario, Canada, N6A 4V2 |
Principal Investigator: | Dwight Moulin, Dr. | University of Western Ontario, Canada |
Responsible Party: | Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT01669967 |
Other Study ID Numbers: |
R11-132 17806 ( Other Identifier: University of Western Ontario ) |
First Posted: | August 21, 2012 Key Record Dates |
Last Update Posted: | March 15, 2019 |
Last Verified: | March 2019 |
Neuralgia Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations Diphenhydramine Promethazine Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |
Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Sleep Aids, Pharmaceutical Hypnotics and Sedatives Antiemetics Autonomic Agents Gastrointestinal Agents Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Anti-Allergic Agents |