Neuropathic PainNCT05731739
IV Lidocaine Infusion for Neuropathic Pain
An observational study of Neuropathic Pain and Complex Regional Pain Syndrome, run by Henry Ford Health System at 1 site in United States.
Trial summary
The investigators will conduct a retrospective cohort study of patients who have undergone i.v. lidocaine infusions in the previous 2 years for suspected neuropathic pain of heterogeneous origin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain, Complex Regional Pain Syndrome, Chronic Pain
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jan 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients' information and their treatment data will be identified through the electronic medical record (EPIC) of the pain management clinic. The investigators will screen sequential charts of previous two years to identify patients who have undergone i.v. lidocaine infusions for Neuropathic Pain of heterogeneous origin (e.g., post-herpetic neuralgia, post surgical nerve injury, lumbar radiculopathy). Inclusion criteria will include: neuropathic pain suspected by the board certified pain specialist assessing the patient based on the presence of allodynia, hyperalgesia, hyperpathia and hyperesthesia or hypesthesia. The exclusion criteria will include patients that refused subsequent i.v. lidocaine infusions or were lost to follow up.
Who may be able to join
- patient with neuropathic pain
- patient enrolled for lidocaine infusion
Who cannot join
- refusal to consent
- lost to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Analysis of Clinical Outcomes of IV Lidocaine Infusion for Neuropathic Pain: Assessing Predictors of Clinically Relevant Analgesia and to Report the Efficacy and Side Effect Profile of Infusion
The investigators will conduct a retrospective cohort study of patients who have undergone i.v. lidocaine infusions in the previous 2 years for suspected neuropathic pain of heterogeneous origin. The investigators hypothesize that the analgesic response to intravenous (i.v.) lidocaine will be bimodal with clear responders and clear non-responders. The investigators also hypothesize that more refractory patients, who have failed previous multimodal analgesic therapy, will be less likely to respond to i.v. lidocaine. The investigators goals are to report what percentage of patients will achieve relief, the degree of relief that can be expected, and identify the type of patients who will most likely to benefit from systemic lidocaine. The investigators secondary objective is to report the correlation between infusion rates and patterns of infusion rate adjustments with regard to efficacy and adverse effects.
Read the detailed description
HYPOTHESIS On the basis of investigators' clinical experience, The investigators hypothesize that the analgesic response to intravenous (i.v.) lidocaine will be bimodal with clear responders and clear non-responders. The investigators also hypothesize that more refractory patients, specifically patients with pain of longer duration and patients who have failed previous multimodal analgesic therapy, will be less likely to respond to i.v. lidocaine. To test the hypotheses, we will identify the distribution of pain relief in the enrolled cohort. The investigators will define responders as patients achieving Numerical Rating Score (NRS) reductions of 30% or greater based on literature defined criteria for meaningful reductions in pain scores.The investigators goals are to report what proportion of patients will achieve relief, the degree of relief that can be expected, and identify the type of patients who will most likely to benefit from systemic lidocaine. The investigators also hypothesize that degree of pain relief in a responder to i.v. lidocaine will be translated in the form of concomitant decrease in quantitative measures of PHQ-9 scales and Oswestry index scales. The investigators secondary objective is to report the correlation between infusion rates and patterns of infusion rate adjustments with regard to efficacy and adverse effects.
DESIGN AND SETTING The investigators will conduct a retrospective cohort study of patients who have undergone IV lidocaine infusions for suspected neuropathic pain. All patients will be recruited from the Pain Management Clinic at Henry Ford Health System.
STUDY PARTICIPANTS The investigators will secure approval from the Institutional Review Board and ethics committee of the institution. The investigators will review patients' information and their treatment data through the electronic medical record (EPIC) of the pain management clinic. The investigators will screen sequential charts of previous two years to identify patients who have undergone i.v. lidocaine infusions for Neuropathic Pain of heterogeneous origin. Inclusion criteria will include: neuropathic pain suspected by the board certified pain specialist assessing the patient based on the presence of allodynia, hyperalgesia, hyperpathia and hyperesthesia or hypesthesia. The exclusion criteria will include patients that refused subsequent i.v. lidocaine infusions or were lost to follow up.
DATA COLLECTION AND INDEPENDENT VARIABLES Independent variables examined will include the patient's age, sex, body mass index, indication, duration of pain problem, dates of treatment, dose, infusion time, adverse events, action taken as a result of an adverse event, duration of treatment, reason for discontinuation, pre and post infusion NRSs of pain, vital signs that were taken pre-infusion, during infusion and post-infusion, previous trials of alternative pain medication and current or previous substance abuse.
STATISTICAL ANALYSIS Initial analysis of patient's age, sex, pain severity, pain duration, number alternative medication tried, with comparison between lidocaine responders and non-responders will be done using Student t test or χ2 test as appropriate. All statistical tests will be 2-sided. A p value less than 0.05 will be considered statistically significant. Normality of data will be assessed with Kolmogorov-Smirnov test. Odds ratios with 95% confidence intervals (CIs) will be calculated. SAS version 9.4 (SAS Institute, Cary, NC) will be used for all analysis.
- Keywords
- LIDOCAINE, NEUROPATHIC PAIN, CHRONIC PAIN
- Medical subject headings
- Neuralgia, Complex Regional Pain Syndromes, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RESPONDERS | The investigators will define responders as patients achieving Numerical Rating Score (NRS) reductions of 30% or greater based on literature defined criteria for meaningful reductions in pain scores | |
| NON RESPONDERS | When a patient failed to respond to the lidocaine infusion, they were given the option to have repeat infusion after four weeks. If no response was obtained, despite two infusions, this was considered as a failure of treatment and no further lidocaine infusions were conducted. Patient will be labelled as a non responder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the type of patients who will most likely to benefit from systemic lidocaine.
Primary aim is to test the hypothesis that the analgesic response to intravenous (i.v.) lidocaine are bimodal with responders and non-responders.
Measured: April, 2016 - August, 2016
Secondary outcomes (2)
Quantify the efficacy of lidocaine infusion in terms of duration of meaningful decrease in pain in patients with neuropathic pain
secondary goals are to report what proportion of patients will achieve clinically meaningful relief, which is defined as >50% reduction in the baseline numeric rating pain score.
Measured: April, 2016 - August, 2016
Our last objective is to report the adverse effects
Will recored recognized side effects (tinnitus, perioral numbnes, dysarthria etc.) which used as a basis for titrating the therapy to minimal effective dose
Measured: April, 2016 - August, 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study startApr 2016
- Primary completionJan 2023
- Study completionJan 2023
Why it stopped: Resources did not come to fruition
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaurav Chauhan, Henry Ford Health System
- Investigators
- NABIL SIBAI, M.D., Study chair, HENRY FORD HEALTH SYSTEMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731739
- Sponsor's protocol ID
- HFHS PAIN MEDICINE
- Status last verified
- Feb 2023
- First submitted
- 6 Apr 2016
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Clinical Outcomes of IV Lidocaine Infusion for Neuropathic Pain: Assessing Predictors of Clinically Relevant Analgesia and to Report the Efficacy and Side Effect Profile of Infusion
- ClinicalTrials.gov ID
- NCT05731739
- Acronym / sponsor ID
- HFHS PAIN MEDICINE
- Keywords
- LIDOCAINE, NEUROPATHIC PAIN, CHRONIC PAIN
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Resources did not come to fruition
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jan 2023 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 16 Feb 2023 (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.
The investigators will conduct a retrospective cohort study of patients who have undergone i.v. lidocaine infusions in the previous 2 years for suspected neuropathic pain of heterogeneous origin. The investigators hypothesize that the analgesic response to intravenous (i.v.) lidocaine will be bimodal with clear responders and clear non-responders. The investigators also hypothesize that more refractory patients, who have failed previous multimodal analgesic therapy, will be less likely to respond to i.v. lidocaine. The investigators goals are to report what percentage of patients will achieve relief, the degree of relief that can be expected, and identify the type of patients who will most likely to benefit from systemic lidocaine. The investigators secondary objective is to report the correlation between infusion rates and patterns of infusion rate adjustments with regard to efficacy and adverse effects.
Detailed description
HYPOTHESIS On the basis of investigators' clinical experience, The investigators hypothesize that the analgesic response to intravenous (i.v.) lidocaine will be bimodal with clear responders and clear non-responders. The investigators also hypothesize that more refractory patients, specifically patients with pain of longer duration and patients who have failed previous multimodal analgesic therapy, will be less likely to respond to i.v. lidocaine. To test the hypotheses, we will identify the distribution of pain relief in the enrolled cohort. The investigators will define responders as patients achieving Numerical Rating Score (NRS) reductions of 30% or greater based on literature defined criteria for meaningful reductions in pain scores.The investigators goals are to report what proportion of patients will achieve relief, the degree of relief that can be expected, and identify the type of patients who will most likely to benefit from systemic lidocaine. The investigators also hypothesize that degree of pain relief in a responder to i.v. lidocaine will be translated in the form of concomitant decrease in quantitative measures of PHQ-9 scales and Oswestry index scales. The investigators secondary objective is to report the correlation between infusion rates and patterns of infusion rate adjustments with regard to efficacy and adverse effects.
DESIGN AND SETTING The investigators will conduct a retrospective cohort study of patients who have undergone IV lidocaine infusions for suspected neuropathic pain. All patients will be recruited from the Pain Management Clinic at Henry Ford Health System.
STUDY PARTICIPANTS The investigators will secure approval from the Institutional Review Board and ethics committee of the institution. The investigators will review patients' information and their treatment data through the electronic medical record (EPIC) of the pain management clinic. The investigators will screen sequential charts of previous two years to identify patients who have undergone i.v. lidocaine infusions for Neuropathic Pain of heterogeneous origin. Inclusion criteria will include: neuropathic pain suspected by the board certified pain specialist assessing the patient based on the presence of allodynia, hyperalgesia, hyperpathia and hyperesthesia or hypesthesia. The exclusion criteria will include patients that refused subsequent i.v. lidocaine infusions or were lost to follow up.
DATA COLLECTION AND INDEPENDENT VARIABLES Independent variables examined will include the patient's age, sex, body mass index, indication, duration of pain problem, dates of treatment, dose, infusion time, adverse events, action taken as a result of an adverse event, duration of treatment, reason for discontinuation, pre and post infusion NRSs of pain, vital signs that were taken pre-infusion, during infusion and post-infusion, previous trials of alternative pain medication and current or previous substance abuse.
STATISTICAL ANALYSIS Initial analysis of patient's age, sex, pain severity, pain duration, number alternative medication tried, with comparison between lidocaine responders and non-responders will be done using Student t test or χ2 test as appropriate. All statistical tests will be 2-sided. A p value less than 0.05 will be considered statistically significant. Normality of data will be assessed with Kolmogorov-Smirnov test. Odds ratios with 95% confidence intervals (CIs) will be calculated. SAS version 9.4 (SAS Institute, Cary, NC) will be used for all analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RESPONDERS | – | –The investigators will define responders as patients achieving Numerical Rating Score (NRS) reductions of 30% or greater based on literature defined criteria for meaningful reductions in pain scores |
| NON RESPONDERS | – | –When a patient failed to respond to the lidocaine infusion, they were given the option to have repeat infusion after four weeks. If no response was obtained, despite two infusions, this was considered as a failure of treatment and no further lidocaine infusions were conducted. Patient will be labelled as a non responder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients' information and their treatment data will be identified through the electronic medical record (EPIC) of the pain management clinic. The investigators will screen sequential charts of previous two years to identify patients who have undergone i.v. lidocaine infusions for Neuropathic Pain of heterogeneous origin (e.g., post-herpetic neuralgia, post surgical nerve injury, lumbar radiculopathy). Inclusion criteria will include: neuropathic pain suspected by the board certified pain specialist assessing the patient based on the presence of allodynia, hyperalgesia, hyperpathia and hyperesthesia or hypesthesia. The exclusion criteria will include patients that refused subsequent i.v. lidocaine infusions or were lost to follow up.
Key inclusion criteria (2 listed)
- patient with neuropathic pain
- patient enrolled for lidocaine infusion
Key exclusion criteria (2 listed)
- refusal to consent
- lost to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify the type of patients who will most likely to benefit from systemic lidocaine.
Time frame: April, 2016 - August, 2016
Primary aim is to test the hypothesis that the analgesic response to intravenous (i.v.) lidocaine are bimodal with responders and non-responders.
2 secondary outcomes
Quantify the efficacy of lidocaine infusion in terms of duration of meaningful decrease in pain in patients with neuropathic pain
Time frame: April, 2016 - August, 2016
Our last objective is to report the adverse effects
Time frame: April, 2016 - August, 2016
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- 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.
NABIL SIBAI, M.D. study chair
HENRY FORD HEALTH SYSTEMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain and Complex Regional Pain Syndrome, run by Henry Ford Health System at 1 site in United States.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 16 Feb 2023. 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 United States. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Identify the type of patients who will most likely to benefit from systemic lidocaine. (time frame: April, 2016 - August, 2016). 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 16 Feb 2023.