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

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lidocaine
Diphenhydramine
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neuropathic Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Joseph's Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Diphenhydramine(Benadryl)

Lidocaine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hospital Anxiety and Depression Scale
Modified Brief Pain Inventory
Leeds Sleep Evaluation Questionnaire
Patient Global Satisfaction with Treatment and Impression of Change
Side Effects
Quality of Life Health Outcome Instrument

Full Information

First Posted
June 22, 2012
Last Updated
March 13, 2019
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01669967
Brief Title
The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
Official Title
The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dwight Moulin, Dr.
Organizational Affiliation
University of Western Ontario, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
31098961
Citation
Moulin DE, Morley-Forster PK, Pirani Z, Rohfritsch C, Stitt L. Intravenous lidocaine in the management of chronic peripheral neuropathic pain: a randomized-controlled trial. Can J Anaesth. 2019 Jul;66(7):820-827. doi: 10.1007/s12630-019-01395-8. Epub 2019 May 16.
Results Reference
derived

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

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