Postherpetic neuralgia Nervous System Diseases
Conditions
Interventions
Patient enrollment and allocation:
Eligible patients will be admitted to hospital and included in the study after screening and signing the informed consent, then, they will be 1:1 ran
Sponsors
Science and Technology Commission of Shanghai Municipality
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 50 years = age = 80 years, regardless of gender. 2. Active post-herpetic neuralgia with refractory pain more than 30 days after rash onset. 3. Stable anti-neuropathic-pain therapy according to the guidelines of IASP NeuPSIG (> 7 days), still VAS = 50mm. 4. Ability to objectively describe symptoms, actively follow the physician's medication recommendation and cooperate with physicians for diagnosis, treatment and follow-up. 5. Written informed consent to study participation.
Exclusion criteria
Exclusion criteria: 1. Contraindications to epidural catheterization or opioids 2. Allergy to medications or devices related to the trail 3. Cognitive deficits compromising the ability to assess pain or pain relief 4. Previous therapy with hydromorphone or morphine 5. Pregnancy or breastfeeding 6. Drug abuse or drug addiction history 7. Severe hepatic and/or renal impairment 8. Epidural anesthesia in last 3 months 9. Participation in other clinical trials that might interfere with the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain intensity in the first three days measured with VAS, twice a day, at 09:00 and 21:00, after epidural opioid infusion, calculated as the average value of VAS during treatment at 1, 2 and 3 days after drug administration is the main outcome measure. The time point for pain assessment during the long-term follow-up phase will be the 7th day, 14th day, 21st day, 28th day, 60th day and 90th day after the start of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Daily occurrence of breakthrough pain measured using pain diary kept by participants, daily from baseline to end of study. 2. Quality of Life (QoL) measured using WHOQOL-OLD 3. PCA bolus press number (no. of patient-controlled epidural analgesia button press during the treatment), during the treatment days (the 1st day, 2nd day, 3rd day after the start of the treatment). 4. Assessment of anxious/depressive disorders (scored with GAD-7 and PHQ-9) at baseline, the 1st day, 2nd day, 3rd day, 7th day, 14th day, 21st day, 28th day, 60th day and 90th day after the start of treatment. 5. Safety & Tolerability, including opioid-related side effects and Epidural procedure related complications (adverse drug reactions, adverse events and serious adverse events occurring during the study) measured using patient self-report, reviewing patients' notes, patient interviews, medical records, etc. throughout the study period. | — |
Countries
China
Outcome results
None listed