NCT01669967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

4.3 years

First QC Date

June 22, 2012

Last Update Submit

March 13, 2019

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

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

    every 24 hours for four weeks post-infusion

Secondary Outcomes (6)

  • Hospital Anxiety and Depression Scale

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

  • Modified Brief Pain Inventory

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

  • Leeds Sleep Evaluation Questionnaire

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

  • Patient Global Satisfaction with Treatment and Impression of Change

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

  • Side Effects

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

  • +1 more secondary outcomes

Study Arms (2)

Diphenhydramine(Benadryl)

PLACEBO COMPARATOR
Drug: Diphenhydramine

Lidocaine

ACTIVE COMPARATOR
Drug: Lidocaine

Interventions

LidocaineDRUG

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

Also known as: Xylocaine
Lidocaine
DiphenhydramineDRUG

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

Also known as: Benadryl
Diphenhydramine(Benadryl)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 31098961DERIVED

MeSH Terms

Conditions

Neuralgia

Interventions

LidocaineDiphenhydramine

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthylaminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Dwight Moulin, Dr.

    University of Western Ontario, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2012

First Posted

August 21, 2012

Study Start

September 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 15, 2019

Record last verified: 2019-03

Locations

CA(1)