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

NCT ID: NCT02763592

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-04-30

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.

Conditions

Allodynic Symptoms; Localized Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine

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

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

placebo plaster

Intervention Type: OTHER

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.

Interventions

Lidocaine

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

Intervention Type: DRUG

placebo plaster

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.

Intervention Type: OTHER

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gisèle PICKERING

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 31009419 (View on PubMed)

Other Identifiers

RBHP 2015 PICKERING 4

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-0261

Identifier Type: -

Identifier Source: org_study_id