Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05731739 |
| Other study ID # |
HFHS PAIN MEDICINE |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 2016 |
| Est. completion date |
January 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Henry Ford Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
