Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain

Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.

The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.

Study Overview

• Status: Terminated
• Conditions: Pain; Chronic Pain; Postoperative Pain; Neuropathic Pain
• Intervention / Treatment: Drug: Placebo topical plaster; Drug: Lidocaine 5% medicated plaster

Detailed Description

Some patients who undergo different types of surgery develop distressing and long-lasting pain. This pain is often characterized by signs such as: allodynia (a pain due to a stimulus which does not normally provoke pain), dysesthesia (unpleasant, abnormal sense of touch). Patients describe symptoms of burning or electrical type sensation. In some cases this type of chronic pain can still be present after 3 months or more following surgery.This clinical trial will assess the efficacy and safety profile of lidocaine 5% medicated plaster in comparison to placebo plaster in patients.

This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), placebo-controlled, parallel-group, multicenter trial to evaluate topical analgesic treatment of chronic neuropathic pain after surgery. The trial will include a screening phase and a treatment phase, during which subjects will be treated with either 5% lidocaine medicated plaster, or a placebo plaster pain intensity will be assessed on a daily basis. Subsequently there will be a follow-up phase. Pain intensity numeric rating scale (PI) will be collected via the numeric rating scale and averaged. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Abbeville, France
    • Site 31
  • Bayonne, France
    • Site 26
  • Bobigny, France
    • Site 34
  • Bordeaux, France
    • Site 35
  • Boulogne-Billancourt, France
    • Site 12
  • Brest, France
    • Site 24
  • Chateauroux, France
    • Site 15
  • Corbeil Essonnes, France
    • Site 30
  • La Roche Sur Yon, France
    • Site 39
  • Lille cedex, France
    • Site 23
  • Limoges, France
    • Site 17
  • Marseille, France
    • Site 21
  • Montauban, France
    • Site 33
  • Nice Cedex 1, France
    • Site 14
  • Orleans, France
    • Site 18
  • Paris, France
    • Site 27
  • Paris, France
    • Site 36
  • Rennes Cedex, France
    • Site 22
  • Saint Genis Laval, France
    • Site 19
  • Saint-Etienne cedex 2, France
    • Site 20
  • Tours, France
    • Site 38
  • Voiron, France
    • Site 28

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects with >= 18 years of age
• Intact skin in the area of topical treatment
• Patients suffering from moderate to severe ( 5 or more points on an 11 point Numerical Rating Scale where 10 is the worst possible pain, and 0 indicates no pain) chronic daily postoperative neuropathic pain for the past 6 to 24 months.
• Patients should have symptoms for example allodynia (a pain due to a stimulus which does not normally provoke pain); and or dysesthesia (unpleasant, abnormal sense of touch).

Exclusion Criteria:

• Contraindications to lidocaine 5% medicated plaster, or paracetamol
• Evidence or history of alcohol, medication or drug abuse and/or dependency in the past 3 years.
• Evidence or history (during the past 3 years) of epilepsy, neurotic personality, psychiatric illness, or suicide risk.
• Pregnant or breastfeeding women
• Women of childbearing potential who are sexually active without satisfactory contraception for at least 28 days prior to enrollment, during the trial, and until 28 days after the follow-up visit.
• Severe renal, hepatic or heart disorder.
• Surgery in the past 3 months before screening.
• Anticipated need for surgery during the trial, requiring at least regional or general anesthesia.
• Pending litigation due to chronic pain or disability.
• Participation in another trial of investigational medicinal products or devices parallel to or less than 1 month before entry into the trial, or previous participation in this trial.
• Presence of other severe pain that could confound the assessment or self- evaluation of the localized postoperative neuropathic pain.
• For patients with chronic postoperative neuropathic pain related to a surgery due to tumors: suspected residual tumor or metastases, chemotherapy or radiotherapy for treatment of tumor(s).
• Total anesthesia in the area of localized chronic pain

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Plaster; Active Comparator	Drug: Placebo topical plaster; Topical hydrogel plaster
ACTIVE_COMPARATOR: Lidocaine Plaster	Drug: Lidocaine 5% medicated plaster; Topical hydrogel plaster (700mg lidocaine); Other Names: Versatis(R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain	Participants will be selected based on their medical history and clinical examination. A questionnaire called DN4, which stands for 'douleur neuropathique 4' (i.e., '4 questions neuropathic pain will be used to identify subjects with neuropathic pain.) Pain will be assessed on and 11-point numerical rating scale (0 = no pain, 10 = worst pain imaginable). Efficacy of the treatment (i.e., reduction of neuropathic pain) will be evaluated with the 11-point numeric rating scale (NRS).	daily assessments over 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of lidocaine 5% medicated plaster on quality of life	EuroQol-5 Dimension Scores	4 weeks
Neuropathic Pain Symptoms	Changes in severity of various neuropathic pain symptoms, e.g. allodynia, will be recorded by the Neuropathic Pain Symptom Inventory (NPSI) and neurological examinations	4 weeks
Incidence of adverse events	Measurement of adverse events including those derived from laboratory data or vital signs measurements.	up to 44 days
Hospital Anxiety and Depression Scale		4 weeks
Subject's Global Impression of Change		4 weeks
Treatment Satisfaction Questionnaire for Medication		4 weeks

Collaborators and Investigators

• Sponsor: Grünenthal GmbH
• Investigators: Principal Investigator: Jean Bruxelle, Fondation Ophtalmologique Adolphe de Rotschild, Service de Neurochirurgie, CEntre d'Evaluation et de Traitement de la Douleur

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: July 1, 2010
• First Submitted That Met QC Criteria: July 1, 2010
• First Posted (ESTIMATE): July 2, 2010

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: chronic pain; analgesic; pain; analgesics; neuropathic pain; postoperative pain; localized pain; focal pain; topical analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain, Postoperative; Chronic Pain; Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 761541; 2009-016337-10 (EUDRACT_NUMBER)