Post operative neuropathic pain (PONP) MedDRA version: 18.1 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Versatis® 5% emplâtre médicamenteux
Product Name: Versatis® 5% emplâtre médicamenteux
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: .
Other descriptive name: LIDOCAINE
Concen
Sponsors
CHU Clermont-Ferrand
Eligibility
Sex/Gender
All
Inclusion criteria
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=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: - Pregnant or breastfeeding women of childbearing potential who are sexually active without satisfactory contraception - Hypersensitivity to the Investigational Medicinal Product (IMP), its excipients, or anesthetics of the amide type - Patient treated by anti-arythmics (Class I) such as tocainide, méxilétine or other local anesthesic - Medical and/or surgical history that the investigator or his/her representative considers to be incompatible with the trial. - Ongoing pathology on the day of the inclusion (open wound, infection, …) - Patient currently enrolled in another clinical trial involving the use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or being in an exclusion period according to the French law, or having received a total amount of compensation higher than 4500 euros over the 12 months preceding the beginning of the trial - Patient benefiting from a legal protective measure (guardianship, curatorship).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate whether neuropathic pain symptoms (dynamic mechanical allodynia, pressure, hot and cold) have a different chronological improvement with 5LP compared to placebo. ;Secondary Objective: The secondary objectives will evaluate neuropathic pain (using the DN4 questionnaire for screening), qualitative and quantitative changes of allodynic symptoms (brush-induced Dynamic Mechanical Allodynia (DMA), Mechanical pressure Threshold (MDT), Cold (CDT) and Warm Thermal Detection (WDT) Thresholds), pain intensity (global pain by numerical scale (GP)), pain relief (NSr), patient global impression of change (PGIC), quality of sleep (Pittsburgh Sleep Quality Index (PSQI)), quality of life (SF12), Osteoarthritis severity (Western Ontario and McMaster Universities (WOMAC)), patients responders 30 % and 50 % and safety.;Primary end point(s): 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. Outcome defined as censored data and treated using appropriate statistical methods (Kaplan-Meier for univariate analysis and Cox proportional hazards model in multivariate context). ;Timepoint(s) of evaluation of this end point: Inclusion (Day 0), Visit 2 (Day 7), Visit 3 (Day 15), Visit 4 (month 1), Visit 5 (Month 2), Visit 6 (Month 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Kinetics of evolution over time of the allodynic symptoms (pressure, hot, cold) obtained in both groups (Placebo and 5LP). 2) Analysis (quantitative and qualitative) of the pathophysiology of neuropathic characteristics and DN4 questionnaire (at inclusion only) 3) Evolution of the size of the allodynic area 4) Responder rate, defined as 30% and 50% reduction over time on all allodynic symptoms 5) Comparison of DMA, MDT, CDT and WDT to contralateral knee on the same anatomic location. 6) Evolution of sleep and quality of life, patient global impression of change, osteoarthritis severity 7) Compliance with treatment 8) Safety and Adverse events ;Timepoint(s) of evaluation of this end point: Inclusion (Jour 0), Visite 2 (Jour 7), Visite 3 (Jour 15), Visite 4 (Mois 1), Visite 5 (Mois 2), Visite 6 (Mois 3) | — |
Countries
France
Contacts
Public ContactLACARIN
CHU Clermont-Ferrand
Outcome results
None listed