Neuropathic PainNCT01669967
The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
A study testing Lidocaine and Diphenhydramine in people with Neuropathic Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Lidocaine and Diphenhydramine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About 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.
Read the 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.
- Conditions
- Neuropathic Pain
- Being tested
- Lidocaine, Diphenhydramine
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Xylocaine
Lidocaine 5 mg/kg in 250 ml of normal saline infused over 45 minutes.
DiphenhydramineDrug
Also called Benadryl
Diphenhydramine 50 mg in 250 ml of normal saline infused over 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Diphenhydramine(Benadryl) | Placebo comparator | Not described Receives: Drug: Diphenhydramine |
| Lidocaine | Active comparator | Not described Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline Pain scores on the Visual Analog Scale at 4 weeks
Measured: every 24 hours for four weeks post-infusion
Secondary outcomes (6)
Hospital Anxiety and Depression Scale
Measured: obtained baseline, 24 and 72 hours and then weeks 1,2,3, and 4
Modified Brief Pain Inventory
Measured: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
Leeds Sleep Evaluation Questionnaire
Measured: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
Patient Global Satisfaction with Treatment and Impression of Change
Measured: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
Side Effects
Measured: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
Quality of Life Health Outcome Instrument
Measured: obtained baseline, 24, 72 hours and then weeks 1,2,3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dwight Moulin, Dr., Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669967
- Sponsor's protocol ID
- R11-132
- Other IDs
- 17806
- Status last verified
- Mar 2019
- First submitted
- 22 Jun 2012
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31098961
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
- ClinicalTrials.gov ID
- NCT01669967
- Acronym / sponsor ID
- R11-132
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diphenhydramine(Benadryl) | Placebo comparator | Drug: Diphenhydramine |
| Lidocaine | Active comparator | Drug: Lidocaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: XylocaineLidocaine 5 mg/kg in 250 ml of normal saline infused over 45 minutes. | Drug | Lidocaine |
| DiphenhydramineAlso: BenadrylDiphenhydramine 50 mg in 250 ml of normal saline infused over 45 minutes. | Drug | Diphenhydramine(Benadryl) |
Primary outcome
Changes from Baseline Pain scores on the Visual Analog Scale at 4 weeks
Time frame: every 24 hours for four weeks post-infusion
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Derived from this study: PubMed 31098961Moulin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dwight Moulin, Dr. principal investigator
University of Western Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Diphenhydramine in people with Neuropathic Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline Pain scores on the Visual Analog Scale at 4 weeks (time frame: every 24 hours for four weeks post-infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01669967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.