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

University Hospital, Clermont-Ferrand

Status and phase: Completed; Phase 2

Conditions: Localized Neuropathic Pain; Allodynic Symptoms

Treatments: Other: placebo plaster; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02763592

RBHP 2015 PICKERING 4 (Other Identifier)

CHU-0261

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 2 patient groups, including a placebo group

Lidocaine

Experimental group

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

Treatment:

Drug: Lidocaine

placebo

Placebo Comparator group

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

Treatment:

Other: placebo plaster