Clinical trial NCT02763592: Impact of 5% Lidocaine Medicated Plaster on Allodynic Symptoms of Localized Neuropathic Pain After Knee Surgery
Official title: Impact of 5% Lidocaine Medicated Plaster on Allodynic Symptoms of Localized Neuropathic Pain After Knee Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allodynic Symptoms
Localized Neuropathic Pain
Keywords: Localized Neuropathic pain
5% lidocaine medicated plaster
Knee surgery
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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\<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:

-

Primary outcomes:
measure: Time to response to treatment
timeFrame: from inclusion to 3 months
Secondary outcomes:
measure: - 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)
timeFrame: from inclusion to 3 months
measure: - 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)
timeFrame: at inclusion
measure: - Kinetics of evolution over time of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) in both groups (Placebo and 5LP)
timeFrame: at inclusion
measure: Pain evaluated with numerical rating scale ranging from 0 to 10
timeFrame: at inclusion
measure: Pathophysiology of neuropathic characteristics with DN4 questionnaire
timeFrame: at inclusion
measure: Evolution of the size of the allodynic area
timeFrame: at inclusion
measure: - Responder rate, defined as 30% and 50% reduction over time on pain evaluated by numeric scale ranging from 0 to 10 with brush-induced Dynamic Mechanical Allodynia (DMA)
timeFrame: at 3 months
measure: - Responder rate, defined as 30% and 50% reduction over time on pain evaluated by numeric scale ranging from 0 to 10 with Mechanical Detection Threshold (MDT)
timeFrame: at 3 months
measure: - Responder rate, defined as 30% and 50% reduction over time on Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT)
timeFrame: at 3 months
measure: - Comparison of pain evaluated by numeric scale ranging from 0 to 10 with brush-induced Dynamic Mechanical Allodynia (DMA) between painful knee and contralateral knee on the same anatomic location.
timeFrame: at 3 months
measure: - Comparison of pain evaluated by numeric scale ranging from 0 to 10 with Mechanical Detection Threshold (MDT) between painful knee and contralateral knee on the same anatomic location
timeFrame: at 3 months
measure: - Comparison of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) between painful knee and contralateral knee on the same anatomic location.
timeFrame: at 3 months
measure: Evolution of sleep by Pittsburgh Sleep Quality Index (PGIC) questionnaire.
timeFrame: at 3 months
measure: Evolution of quality of life by Short-Form 12 (SF-12) questionnaire.
timeFrame: at 3 months
measure: Evolution of Patient Global Impression of Change (PGIC) questionnaire
timeFrame: at 3 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle PICKERING
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pickering G, Voute M, Macian N, Ganry H, Pereira B. Effectiveness and safety of 5% lidocaine-medicated plaster on localized neuropathic pain after knee surgery: a randomized, double-blind controlled trial. Pain. 2019 May;160(5):1186-1195. doi: 10.1097/j.pain.0000000000001502.