Clinical trial NCT01155986: Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain
Official title: Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Chronic Pain
Neuropathic Pain
Postoperative Pain
Keywords: analgesic
analgesics
pain
chronic pain
localized pain
focal pain
neuropathic pain
postoperative pain
topical analgesia
Lead sponsor: Grünenthal GmbH
Sponsor class: INDUSTRY
First posted: 2010-07-02
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain
timeFrame: daily assessments over 4 weeks
Secondary outcomes:
measure: Effect of lidocaine 5% medicated plaster on quality of life
timeFrame: 4 weeks
measure: Neuropathic Pain Symptoms
timeFrame: 4 weeks
measure: Incidence of adverse events
timeFrame: up to 44 days
measure: Hospital Anxiety and Depression Scale
timeFrame: 4 weeks
measure: Subject's Global Impression of Change
timeFrame: 4 weeks
measure: Treatment Satisfaction Questionnaire for Medication
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Abbeville
country: France
facility: Site 31
city: Bayonne
country: France
facility: Site 26
city: Bobigny
country: France
facility: Site 34
city: Bordeaux
country: France
facility: Site 35
city: Boulogne-Billancourt
country: France
facility: Site 12
city: Brest
country: France
facility: Site 24
city: Chateauroux
country: France
facility: Site 15
city: Corbeil Essonnes
country: France
facility: Site 30
city: La Roche Sur Yon
country: France
facility: Site 39
city: Lille cedex
country: France
facility: Site 23
city: Limoges
country: France
facility: Site 17
city: Marseille
country: France
facility: Site 21
city: Montauban
country: France
facility: Site 33
city: Nice Cedex 1
country: France
facility: Site 14
city: Orleans
country: France
facility: Site 18
city: Paris
country: France
facility: Site 27
city: Paris
country: France
facility: Site 36
city: Rennes Cedex
country: France
facility: Site 22
city: Saint Genis Laval
country: France
facility: Site 19
city: Saint-Etienne cedex 2
country: France
facility: Site 20
city: Tours
country: France
facility: Site 38
city: Voiron
country: France
facility: Site 28
Study officials:
affiliation: Fondation Ophtalmologique Adolphe de Rotschild, Service de Neurochirurgie, CEntre d'Evaluation et de Traitement de la Douleur
name: Jean Bruxelle
role: PRINCIPAL_INVESTIGATOR
References: