Chronic Pain SyndromeNCT03249025
Lidocaine-Ketamine for Management of Chronic Pain
A study testing Lidocaine and Ketamine in people with Chronic Pain Syndrome, run by Hamilton Health Sciences Corporation.
Trial summary
Chronic pain is defined as 'an unpleasant sensory and emotional experience associated with actual or potential tissues damage, or described in terms of such damage". It is estimated that 1 in 5 Canadians experience chronic pain "Chronic pain is associated with the worst quality of life compared with other chronic… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Pain Syndrome
- What is being tested?
- Lidocaine and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 1 Sep 2018
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-90
- Pain duration: > 3 months
- Multifocal and/or non-dermatomal neuropathic pain per Pain Diagram
- Failed medical management with at least 2 neuromodulation agents (e.g., gabapentinoids, antidepressants)
- Neuropathic component (>15 points on S-LANSS)
Who cannot join
- Non-English speakers
- Refusal to sign informed consent
- Body weight > 100 kg
- Allergies to ketamine and/or lidocaine
- Known contraindications to ketamine use which include poorly controlled systemic illnesses: arterial hypertension, hyperthyroidism, ischemic heart disease, heart failure, psychiatric comorbidity (e.g., history of psychosis, schizophrenia, dissociative state).
- Known contraindication to lidocaine use which include current symptomatic or clinically significant brady- or tachyarrhythmia, systolic blood pressure <90 or >180 mmHg.
- Scheduled interventions targeting neuropathic pain: epidural injections, peripheral nerve blocks, Bier block, radiofrequency of dorsal root ganglia and peripheral nerves, additional lidocaine or ketamine infusions
- Newly added analgesic or neuromodulating medications, or recently performed interventions including lidocaine infusions (in the previous 3 months), or previous lidocaine/ketamine infusion in the previous 360 days. -Acute intoxication or active illegal substance abuse (excluding marijuana)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ambulatory Infusion of Lidocaine and Ketamine for Management of Chronic Pain: An Observational Prospective Study
Chronic pain is defined as 'an unpleasant sensory and emotional experience associated with actual or potential tissues damage, or described in terms of such damage". It is estimated that 1 in 5 Canadians experience chronic pain "Chronic pain is associated with the worst quality of life compared with other chronic diseases such as chronic lung or heart disease". Many of these problems are confined to a specific anatomic structure, and can be diagnosed and treated by injections, physical therapy, surgery, etc. Nonetheless, other individuals experience a more generalized pain. This condition has also resulted I depressed mood, bad relations with other people, sleep disturbances and poor quality of life.
The condition is very difficult to manage, and multiple methods have been recommended. Therapeutic intravenous infusion may be considered as one of these methods. Patients come for infusions of non-opioid medications under medical supervision and in a scheduled fashion. Two most commonly used mediation are lidocaine and ketamine.
Even though it is common to use multiple medications with complementary mechanisms of action to treat pain a combined lidocaine-ketamine infusion has never been studied Therefore, the purpose of this research study is to determine whether mixture of two medications (ketamine and lidocaine) infused intravenously 1 time per month for 6 months results in reduction of pain unpleasantness.
- Conditions
- Chronic Pain Syndrome
- Keywords
- lidocaine, ketamine, infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Initial dose of 5.0 mg/kg (based on actual weight, up to maximum dose 600 mg) over 45-60 minutes, followed by increases of 0.5 mg/kg each infusion based on tolerability of side effects, to a maximum total dose of 600 mg. The initial and subsequent dose may be increased or decreased by 20% based on patient comorbidities, age and previous experience
KetamineDrug
initial dose of 0.25 mg/kg (based on actual weight) over 45-60 minutes (rounded to nearest 5 mg), increased by 10mg each infusion based on tolerability of side effects. The initial and subsequent dose may be increased or decreased by 20% based on patient comorbidities, age and previous experience
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine-Ketamine Infusion | Experimental | Lidocaine-Ketamine Infusions 1 time per month for 6 months. Pretreatment with Midazolam 1-3 mg IV Push or Subcutaneously and Clonidine 0.1 mg PO prior to infusion. Receives: Drug: Lidocaine; Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Unpleasantness Score
Relative change on "Pain Unpleasantness Score". Moderate clinically important improvement is considered as 30% reduction.
Measured: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Secondary outcomes (8)
Pain Interference
Less Pain Interference measured by Short Form Brief Pain Inventory (SF-BPI)
Measured: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Neuropathic Pain
Less Neuropathic pain measured by Self-Administered the Leads Assessment of Neuropathic Symptoms and Signs (S-LANSS)
Measured: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Functional Status
Improved Functional Status measured by Patient Self-Efficacy Questionnaire (PSEQ)
Measured: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Emotional Status
Improved Emotional Status measured by Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS)
Measured: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Cognitive Status
No change in Cognitive Status measured by Montreal Cognitive Assessment (MoCA)
Measured: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Quality of Life
Improved Quality of Life measured by Global Improvement and Satisfaction Score
Measured: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Health Care Utilization
Less Health Care Utilization measured by Self-report of number of physician, clinic visits for other reason, emergency department visit and hospitalizations
Measured: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Medication Use
Less Medication Use determined by Type and Dose of medications
Measured: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Sep 2017 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Gofeld, Hamilton Health Sciences Corporation
- Investigators
- Michael Gofeld, MD, FRCPC, Principal investigator, Michael G. DeGroote Pain Clinic, Hamilton Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249025
- Sponsor's protocol ID
- MGD-002-20170705
- Status last verified
- Aug 2017
- First submitted
- 10 Aug 2017
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Infusion of Lidocaine and Ketamine for Management of Chronic Pain: An Observational Prospective Study
- ClinicalTrials.gov ID
- NCT03249025
- Acronym / sponsor ID
- MGD-002-20170705
- Conditions
- Chronic Pain Syndrome
- Keywords
- lidocaine, ketamine, infusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 15 Aug 2017 (actual)
- 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.
Chronic pain is defined as 'an unpleasant sensory and emotional experience associated with actual or potential tissues damage, or described in terms of such damage". It is estimated that 1 in 5 Canadians experience chronic pain "Chronic pain is associated with the worst quality of life compared with other chronic diseases such as chronic lung or heart disease". Many of these problems are confined to a specific anatomic structure, and can be diagnosed and treated by injections, physical therapy, surgery, etc. Nonetheless, other individuals experience a more generalized pain. This condition has also resulted I depressed mood, bad relations with other people, sleep disturbances and poor quality of life.
The condition is very difficult to manage, and multiple methods have been recommended. Therapeutic intravenous infusion may be considered as one of these methods. Patients come for infusions of non-opioid medications under medical supervision and in a scheduled fashion. Two most commonly used mediation are lidocaine and ketamine.
Even though it is common to use multiple medications with complementary mechanisms of action to treat pain a combined lidocaine-ketamine infusion has never been studied Therefore, the purpose of this research study is to determine whether mixture of two medications (ketamine and lidocaine) infused intravenously 1 time per month for 6 months results in reduction of pain unpleasantness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lidocaine-Ketamine Infusion | Experimental | Drug: Lidocaine, Drug: KetamineLidocaine-Ketamine Infusions 1 time per month for 6 months. Pretreatment with Midazolam 1-3 mg IV Push or Subcutaneously and Clonidine 0.1 mg PO prior to infusion. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-90
- Pain duration: > 3 months
- Multifocal and/or non-dermatomal neuropathic pain per Pain Diagram
- Failed medical management with at least 2 neuromodulation agents (e.g., gabapentinoids, antidepressants)
- Neuropathic component (>15 points on S-LANSS)
Key exclusion criteria (8 listed)
- Non-English speakers
- Refusal to sign informed consent
- Body weight > 100 kg
- Allergies to ketamine and/or lidocaine
- Known contraindications to ketamine use which include poorly controlled systemic illnesses: arterial hypertension, hyperthyroidism, ischemic heart disease, heart failure, psychiatric comorbidity (e.g., history of psychosis, schizophrenia, dissociative state).
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 |
|---|---|---|
| LidocaineInitial dose of 5.0 mg/kg (based on actual weight, up to maximum dose 600 mg) over 45-60 minutes, followed by increases of 0.5 mg/kg each infusion based on tolerability of side effects, to a maximum total dose of 600 mg. The initial and subsequent dose may be increased or decreased by 20% based on patient comorbidities, age and previous experience | Drug | Lidocaine-Ketamine Infusion |
| Ketamineinitial dose of 0.25 mg/kg (based on actual weight) over 45-60 minutes (rounded to nearest 5 mg), increased by 10mg each infusion based on tolerability of side effects. The initial and subsequent dose may be increased or decreased by 20% based on patient comorbidities, age and previous experience | Drug | Lidocaine-Ketamine Infusion |
Primary outcome
Pain Unpleasantness Score
Time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Relative change on "Pain Unpleasantness Score". Moderate clinically important improvement is considered as 30% reduction.
8 secondary outcomes
Pain Interference
Time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Neuropathic Pain
Time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Functional Status
Time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Emotional Status
Time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Cognitive Status
Time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Quality of Life
Time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Health Care Utilization
Time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Medication Use
Time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Michael Gofeld, MD, FRCPC principal investigator
Michael G. DeGroote Pain Clinic, Hamilton Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Ketamine in people with Chronic Pain Syndrome, run by Hamilton Health Sciences Corporation.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Patterson, BA (905-521-5100 ext. 74279, pattersl@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Unpleasantness Score (time frame: Baseline, 1, 2, 3, 4, 5, 6 and 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2017.