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

Localized Neuropathic Pain Clinical Trial

— LiNe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763592
• Other study ID #: CHU-0261
• Secondary ID: RBHP 2015 PICKER
• Status: Completed
• Phase: Phase 2
• First received: April 11, 2016
• Last updated: March 31, 2017
• Start date: May 2016
• Est. completion date: April 2017

Study information

• Verified date: March 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

Related Conditions & MeSH terms

• Allodynic Symptoms
• Localized Neuropathic Pain
• Neuralgia

Intervention

Drug:
• 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

Other:
• 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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to response to treatment	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	from inclusion to 3 months
Secondary	- 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)	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)	from inclusion to 3 months
Secondary	- 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)	- 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)	at inclusion
Secondary	- Kinetics of evolution over time of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) in both groups (Placebo and 5LP)	- Kinetics of evolution over time of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) in both groups (Placebo and 5LP)	at inclusion
Secondary	Pain evaluated with numerical rating scale ranging from 0 to 10	Pain evaluated with numerical rating scale ranging from 0 to 10	at inclusion
Secondary	Pathophysiology of neuropathic characteristics with DN4 questionnaire	Pathophysiology of neuropathic characteristics with DN4 questionnaire	at inclusion
Secondary	Evolution of the size of the allodynic area		at inclusion
Secondary	- 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)	- 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)	at 3 months
Secondary	- 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)	- 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)	at 3 months
Secondary	- Responder rate, defined as 30% and 50% reduction over time on Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT)	- Responder rate, defined as 30% and 50% reduction over time on Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT)	at 3 months
Secondary	- 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.	- 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.	at 3 months
Secondary	- 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	- 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	at 3 months
Secondary	- Comparison of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) between painful knee and contralateral knee on the same anatomic location.	- Comparison of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) between painful knee and contralateral knee on the same anatomic location.	at 3 months
Secondary	Evolution of sleep by Pittsburgh Sleep Quality Index (PGIC) questionnaire.	Evolution of sleep by Pittsburgh Sleep Quality Index (PGIC) questionnaire.	at 3 months
Secondary	Evolution of quality of life by Short-Form 12 (SF-12) questionnaire.	Evolution of quality of life by Short-Form 12 (SF-12) questionnaire.	at 3 months
Secondary	Evolution of Patient Global Impression of Change (PGIC) questionnaire	Evolution of Patient Global Impression of Change (PGIC) questionnaire	at 3 months