AzTrials
AzTrials

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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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
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.

United States1 site
  • Henry Ford Health Systems

    Detroit, Michigan, 48202

Other trials in United States

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 groups in NCT05731739
Study groupRoleWhat they receive
RESPONDERSThe 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 RESPONDERSWhen 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted16 Feb 2023
  2. Study startApr 2016
  3. Primary completionJan 2023
  4. Study completionJan 2023

Why it stopped: Resources did not come to fruition

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in