Impact of 5% Lidocaine Medicated Plaster on Allodynic Symptoms of Localized Neuropathic Pain After Knee Surgery

University Hospital, Clermont-Ferrand37 enrolled

Overview

The aim of this study is to evaluate the impact of 5% lidocaine medicated plaster on allodynic symptoms of localized neuropathic pain after knee surgery.

This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial comparing 5% lidocaine medicated plaster (5LP) and placebo whether neuropathic pain symptoms (dynamic mechanical allodynia, pressure, hot and cold) have a different chronological improvement with 5LP compared to placebo. Pain intensity and pain relief, sleep and quality of life and osteoarthritis severity are also assessed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Allodynic Symptoms Localized Neuropathic Pain

Interventions

LidocaineDRUG

The aim of this study is to evaluate the impact of 5% lidocaine medicated plaster on allodynic symptoms of localized neuropathic pain after knee surgery

placebo plasterOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged from 18 to 80 years * Male or female, for women of childbearing potential, a negative pregnancy test * Patients with PONP following knee surgery * Patients with neuropathic pain DN4 ≥ 4 * Patients at least 3 months post-surgery * Patients suffering from at least the allodynic brush-induced mechanical allodynia symptom (DMA) rated as ≥ 5/10 on the numerical scale * Patient with no localized neuropathic pain symptoms (DN4\<4) on the contralateral knee * Intact skin besides the scar of surgery (absence of skin disease, skin irritation, inflammation or injury, such as active herpes zoster lesions, atopic dermatitis, wounds) in the area where the medicated plasters will be applied * Naive from Versatis® treatment * Treated with stable systemic analgesic and planned to remain stable all over the duration of the study * Insured by French social security * Included or agreement to be included in the national register of participants in biomedical research Exclusion Criteria: \-

Locations (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Outcomes

Primary Outcomes

Time to response to treatment

Time to response to treatment defined as a 30% reduction in dynamic brush-induced mechanical allodynia on the localized pain area during the chronological period extending from inclusion to 3 months

Time frame: from inclusion to 3 months

Secondary Outcomes

- Kinetics of evolution over time of pain evaluated by numeric scale ranging from 0 to 10 with brush-induced Dynamic Mechanical Allodynia (DMA) in both groups (Placebo and 5LP)

Kinetics of evolution over time of pain evaluated by numeric scale ranging from 0 to 10 with brush-induced Dynamic Mechanical Allodynia (DMA) in both groups (Placebo and 5LP)

Time frame: from inclusion to 3 months

- Kinetics of evolution over time of pain evaluated by numeric scale ranging from 0 to 10 with Mechanical Detection Threshold (MDT) in both groups (Placebo and 5LP)

\- Kinetics of evolution over time of pain evaluated by numeric scale ranging from 0 to 10 with Mechanical Detection Threshold (MDT) in both groups (Placebo and 5LP)

Time frame: at inclusion

- Kinetics of evolution over time of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) in both groups (Placebo and 5LP)

\- Kinetics of evolution over time of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) in both groups (Placebo and 5LP)

Time frame: at inclusion

Pain evaluated with numerical rating scale ranging from 0 to 10

Time frame: at inclusion

Pathophysiology of neuropathic characteristics with DN4 questionnaire

Data from ClinicalTrials.gov

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