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

This study is currently recruiting participants.
Verified August 2012 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Dwight Moulin, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01669967
First received: June 22, 2012
Last updated: August 20, 2012
Last verified: August 2012

June 22, 2012
August 20, 2012
September 2011
September 2013   (final data collection date for primary outcome measure)
Changes from Baseline Pain scores on the Visual Analog Scale at 6 weeks [ Time Frame: every 24 hours for six weeks post-infusion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01669967 on ClinicalTrials.gov Archive Site
  • Hospital Anxiety and Depression Scale [ Time Frame: obtained baseline, 24 and 72 hours and then weeks 1,2,3, and 4 ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ] [ Designated as safety issue: No ]
  • Leeds Sleep Evaluation Questionnaire [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ] [ Designated as safety issue: No ]
  • Patient Global Satisfaction with Treatment and Impression of Change [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ] [ Designated as safety issue: No ]
  • Side Effects [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ] [ Designated as safety issue: No ]
  • Quality of Life Health Outcome Instrument [ Time Frame: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
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.

This study will examine the role of intravenous lidocaine in the relief of neuropathic pain over four weeks following infusion compared to a salt water infusion. 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Neuropathic Pain
  • Drug: Lidocaine
    Lidocaine 5 mg/kg in 250 ml of normal saline infused over 45 minutes.
    Other Name: Xylocaine
  • Drug: Diphenhydramine
    Diphenhydramine 50 mg in 250 ml of normal saline infused over 45 minutes.
    Other Name: Benadryl
  • Placebo Comparator: Diphenhydramine(Benadryl)
    Intervention: Drug: Diphenhydramine
  • Active Comparator: Lidocaine
    Intervention: Drug: Lidocaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic neuropathic pain of peripheral nerve origin as determined by the study physician 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.
Both
18 Years to 80 Years
No
Not Provided
Canada
 
NCT01669967
R11-132, 17806
No
Dwight Moulin, Lawson Health Research Institute
Lawson Health Research Institute
Not Provided
Principal Investigator: Dwight Moulin, Dr. University of Western Ontario, Canada
Lawson Health Research Institute
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP