Patients with postoperative or posttraumatic neuropathic chronic cutaneous pain
Conditions
Interventions
Trade Name: VERSATIS 5%
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: LIDOCAINE
CAS Number: 137-58-6
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentra
Sponsors
Universitair Ziekenhuis Antwerpen (UZA) - Multidisciplinair Pijncentrum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -NRS > or = 5 and LANSS =65 years) yes F.1.3.1 Number of subjects for this age range 74
Exclusion criteria
Exclusion criteria: -Age 80; -Patients not on a stable medication for at least 3 weeks; -Patients not stable on a TENS treatment during the last 4 weeks, or any other treatment possibly confounding the evaluation of the study results; -Patients continuing use of any topically applied pain relief compound; -Pregnant women or lactating; -Women of chilbearing potential not willing to use an adequate contraception method (all study duration); -Infection in the painful version; -Poorly healed or non-healed wound or scar in the painful region; -Presence of exclusevely negative sensory symptoms (such as hypoesthesia); -The current presence of another chronic pain syndrome that is clincally more pronounced than the PNCCP and/or the opinion of the study investigator that another chronic pain syndrome is present in the patient which may have a significant impact on the evaluation by the patient of the effect of the study medication on the PNCCP; -The presence of postherpetic neuralgia; -The presence of postlamniectomy syndrome namely failed back or neck surgery syndrome with radiculopathy.; -The presence of another form of neuropathic pain and, in particular, painful sensory peripheral polyneuropathy; -Clinical suspicion and/or known presence of sensory disturbances present prior to the occurence of the PNCCP, for example in diabetes mellitus, polyneuropathy due to alcohol, radiation, radiotherapy, chemotherapy etc..(except for patients being in remission, having received for more than 2 years no active cancer treatment); -The presence of neurological disorders such as multiple sclerosis, CVA, spinal and/or brain disorders; -Known and/or strong suspicion of allergy to the study medication, known skin disorder; -Patients using steroid therapy; -History of or present cognitive and/or psychiatric disorder with possible impact on the reporting of the effect of the study medication by the patient; -Patients with ongoing medication litigation procedures are also excluded; -Other reasons according to the estimations of the investigator which may put the study subjects at risk or preclude adherence to the trial protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to evaluate lidocaine patches analgesic efficacy in patients with chronic (present for more than 3 months) postoperative or posttraumatic neuropathic cutaneous pain (PNCCP) in comparison with the situation before therapy (baseline situation) and in comparison with the placebo patches.;Secondary Objective: Secondary objectives of this study consist of the evaluation of the effects of the lidocaine 5% patches, in comparison with placebo patches, on quality of life, intensity of neuropathic pain symptomatology, extent of the painful skin area and use of additionnal analgesics. In addition, impression of change (compared to baseline) will be evaluated both by the patient and by the physician.;Primary end point(s): The intensity of the pain is measured on the weighted 11-point Numeric Rating Scale (NRS) will be measured during the screening visit (before topical treatment with lidocaine patches), at the start of the treatment, at every follow-up visits ( after 3 weeks and 8 weeks) and at the final visit (after 12 weeks).;Timepoint(s) of evaluation of this end point: NRS will be measured during the screening visit (before topical treatment with lidocaine patches), at the start of the treatment, at every follow-up visits to the hospital (after 3 weeks, and 8 weeks) and at the final visit (after 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Patient Global Impression of Change scale (PGIC) = Subjective experience of change in the intensity of pain b) Clinician Global Impression of change scale (CGIC) = Experience of change in the intensity of pain as evaluated by the physician c) Analgesic use is measured in terms of whether there is a reduction in the need of co-analgesics (number of analgesics and daily dose) d) Leeds Assessment of neuropathic Symptoms and Signs pain scale (LANSS) = Effect of study medication on neuropathic pain e) Neuropathic Pain Symptom Inventory scale (NPSI) = Detailed information concerning the presence of different neuropathic symptoms f) EQ-5D standardized questionnaire to measure health outcome g) Effect of the study medication on cutaneous sensory symptoms as measured by pin prick stimulation, sensory brush, and cold & warm h) The size of the painful area i) The average number of patches used on a daily basis j) Occurrence of side effects ;Timepoint(s) of evaluation of this end point: a) After 3 weeks, 8 weeks and 12 weeks b) After 3 weeks, 8 weeks and 12 weeks c) At day -1, after 3 weeks, 8 weeks and 12 weeks d) At day -1, after 3 weeks, 8 weeks and 12 weeks e) At day -1, after 3 weeks, 8 weeks and 12 weeks f) At day -1, after 3 weeks, 8 weeks and 12 weeks g) At day -1, after 3 weeks, 8 weeks and 12 weeks h) At day -1, after 3 weeks, 8 weeks and 12 weeks i) After 3 weeks, 8 weeks and 12 weeks j) At day 10, after 3 weeks, 8 weeks and 12 weeks | — |
Countries
Belgium
Contacts
Public ContactGuy Hans
Universitair Ziekenhuis Antwerpen (UZA) - Multidisciplinair Pijncentrum
Outcome results
None listed