NCT02763592|CompletedPhase 2
Impact of 5% Lidocaine Medicated Plaster on Allodynic Symptoms of Localized Neuropathic Pain After Knee Surgery
LiNe
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LiNe
Sponsor study identifier
Secondary identifiers
OTHER · CHU Clermont-Ferrand
interventional
37
1 country
1
Study Start
May 2016
Actual (reported)Primary Completion
March 2017
Actual (reported)Study Completion
April 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 11, 2016
Actual (reported)May 2016
Actual (reported)May 5, 2016
Actual (reported)March 2017
Actual (reported)April 2017
Actual (reported)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
- 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
- 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
- Kinetics of evolution over time of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) in both groups (Placebo and 5LP)
at inclusion
Pain evaluated with numerical rating scale ranging from 0 to 10
at inclusion
Pathophysiology of neuropathic characteristics with DN4 questionnaire
at inclusion
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
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
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
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.
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
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.
Gisèle PICKERING
University Hospital, Clermont-Ferrand
37 participants (actual enrollment reported by the registry).
First Submitted
April 11, 2016
First Posted
May 5, 2016
Study Start
May 2016
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 2017
Actual (reported)Study Completion
April 2017
Actual (reported)Last Updated
April 4, 2017
Record last verified: 2017-03
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Source: ClinicalTrials.gov.
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