IV Lidocaine Infusion for Neuropathic Pain

NCT05731739 | Withdrawn DMC

• 1 other identifier: HFHS PAIN MEDICINE
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathic Pain; Complex Regional Pain Syndrome; Chronic Pain

Keywords

LIDOCAINE, NEUROPATHIC PAIN, CHRONIC PAIN

Outcome Measures

Primary Outcomes (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.

  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

  April, 2016 - August, 2016

• Our last objective is to report the adverse effects

  April, 2016 - August, 2016

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• patient with neuropathic pain
• patient enrolled for lidocaine infusion

You may not qualify if:

• refusal to consent
• lost to follow-up

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Neuralgia; Complex Regional Pain Syndromes; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases

Study Officials

• NABIL SIBAI, M.D.

  HENRY FORD HEALTH SYSTEMS

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESIDENT ANESTHESIOLOGY

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: February 16, 2023
• Study Start: April 1, 2016
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)