Postherpetic neuralgia
Conditions
Interventions
Experimental group:Lidocaine gel paste
control group:placebo
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled: 1. Male or female subjects aged 18 = 40 mm; 5. On the first day of the screening/single blind placebo introduction period and the first day of the treatment period, the visual analog scale score (VAS) in the McGill Pain Questionnaire must be >= 40mm; 6. Hamilton Depression Rating Scale (HAMD) 17 item version score <= 17 points in screening period; 7. The subject has understood the test content and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: If the subject meets any of the following criteria, he/she cannot be included in the group: 1. Patients with damaged skin surface at the post herpetic neuralgia site; 2. Patients who have received destructive nerve block or neurosurgical ablation for the treatment of herpes zoster related pain; 3. Patients who have received minimally invasive interventional therapy or physical therapy for PHN within one week before screening, including but not limited to neural intervention technology, neural regulation technology, acupuncture treatment, etc; 4. Patients who are receiving drug treatment containing local anesthetic ingredients, or who are using traditional Chinese medicine or proprietary Chinese medicine for pain relief; 5. Patients who are using gabapentin or pregabalin to treat PHN before screening and are unwilling to stop using the drug; 6. Being treated with Class I antiarrhythmic drugs (such as Tocarnet and Mexiletil); 7. Patients receiving opioids and glucocorticoids; 8. Patients who have received treatment for serious cardiorespiratory diseases within 3 months before screening and whose condition is not stable, such as angina pectoris, congestive heart failure, bundle branch block or arrhythmia (including implanted cardiac pacemaker); 9. Patients with malignant blood diseases and other related malignant tumors; 10. The levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in patients with liver and kidney dysfunction were 1.5 times higher than the upper limit of normal values; And/or the level of serum creatinine (SCR) is higher than the upper limit of normal value); 11. Patients who have relevant medical history or are currently suffering from serious mental illness, epilepsy, or other brain diseases or mental disorders that affect their ability to judge themselves; 12. In addition to herpes zoster pain, there are other causes of pain in the herpes zoster area, such as compressive neuropathy (spinal stenosis), fibromyalgia, etc., or before the diagnosis of PHN, there are other painful diseases in the local area, which will affect the evaluation of pain perception in this trial; 13. There are other serious pain diseases, which may confuse the subject's self-evaluation of pain caused by PHN according to the judgment of the investigator; 14. There are other nervous system diseases (such as cognitive impairment), which may affect the evaluation of PHN or the ability of subjects to complete the diary card; 15. Patients with allergies or contraindications to any of the drugs or excipients allowed to be used in the Lidocaine (including other amides) local anesthetic, NSAIDs, paracetamol and other protocols; 16. Subjects whose difference between any two reported pain scores in the screening/single blind placebo introduction period is>30mm; 17. Lactating or pregnant women, or subjects with pregnancy plans (or partners with pregnancy plans) during the trial; 18. Those who have a history of alcohol abuse, drug abuse and drug abuse; 19. Those who have participated in or are participating in other clinical trials within 1 month before screening; 20.Patients judged by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average value of VAS score in the fourth week of medication, compared with the average value of VAS in the screening/single blind placebo introduction period; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients whose average VAS score decreased by 30% compared with the average VAS score in the screening/placebo introduction period in the fourth week of medication (using the VAS score in the daily pain diary card of subjects);;The proportion of patients whose average VAS score decreased by 50% compared with the average VAS score in the screening/placebo introduction period in the fourth week of medication (using the VAS score in the daily pain diary card of the subjects);;The change of the pain rating index (PRI) in the McGill pain questionnaire on the 28th day of treatment compared with the 10th day;;Changes in the current pain intensity index (PPI) in the McGill pain questionnaire on the 28th day of treatment compared with the 10th day;;Early disengagement rate.; | — |
Countries
China
Contacts
Public ContactLi Hang
Peking University First Hospital
Outcome results
None listed