Skip to main content
OpenTrials
Completed

NCT Number: NCT02763592

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allodynic Symptoms Localized Neuropathic Pain

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Lidocaine

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 plaster

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.

Primary outcomes

  1. Time to response to treatment

    Time frame: from inclusion to 3 months

    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

Secondary outcomes

  1. - 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 brush-induced Dynamic Mechanical Allodynia (DMA) in both groups (Placebo and 5LP)

  2. - 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 pain evaluated by numeric scale ranging from 0 to 10 with Mechanical Detection Threshold (MDT) in both groups (Placebo and 5LP)

  3. - 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

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

  4. Pain evaluated with numerical rating scale ranging from 0 to 10

    Time frame: at inclusion

    Pain evaluated with numerical rating scale ranging from 0 to 10

  5. Pathophysiology of neuropathic characteristics with DN4 questionnaire

    Time frame: at inclusion

    Pathophysiology of neuropathic characteristics with DN4 questionnaire

  6. Evolution of the size of the allodynic area

    Time frame: at inclusion

  7. - 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)

    Time frame: at 3 months

    • 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)

  8. - 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)

    Time frame: at 3 months

    • 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)

  9. - Responder rate, defined as 30% and 50% reduction over time on Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT)

    Time frame: at 3 months

    • Responder rate, defined as 30% and 50% reduction over time on Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT)

  10. - 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.

    Time frame: at 3 months

    • 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.

  11. - 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

    Time frame: at 3 months

    • 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

  12. - Comparison of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) between painful knee and contralateral knee on the same anatomic location.

    Time frame: at 3 months

    • Comparison of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) between painful knee and contralateral knee on the same anatomic location.

  13. Evolution of sleep by Pittsburgh Sleep Quality Index (PGIC) questionnaire.

    Time frame: at 3 months

    Evolution of sleep by Pittsburgh Sleep Quality Index (PGIC) questionnaire.

  14. Evolution of quality of life by Short-Form 12 (SF-12) questionnaire.

    Time frame: at 3 months

    Evolution of quality of life by Short-Form 12 (SF-12) questionnaire.

  15. Evolution of Patient Global Impression of Change (PGIC) questionnaire

    Time frame: at 3 months

    Evolution of Patient Global Impression of Change (PGIC) questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: LiNe

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 5, 2016
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.