Postherpetic neuralgia Infections and Infestations Zoster [herpes zoster]
Conditions
Interventions
Administration of 60 mg lidocaine (intrathecal) with or without 60 mg methylprednisolone (intrathecal).
Sponsors
University Medical Centre Utrecht (UMCU), Department of Perioperative Care and First Aid (DPenS) (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatient, male or female, aged 18 years or older 2. History of PHN for at least 6 months after onset of the vesicular eruption 3. Global pain intensity due to PHN must be at least 40 mm on 100 mm Visual Analogue Scale (VAS) for the last 24 hours despite conventional therapies, as recorded at Visit 1 4. The PHN must be restricted to the dermatomes involved in the original eruption of herpes zoster 5. Patient does not use concomitant medication for PHN, or is using concomitant PHN medication on a stable dose for at least 4 weeks prior to randomisation 6. Patients must be willing and able to give informed consent
Exclusion criteria
Exclusion criteria: 1. PHN in regions innervated by the trigeminal nerve 2. Previous neurolytic or neurosurgical treatment for PHN (radiofrequency neuroablation [RF] treatment of the dorsal root ganglion is allowed) 3. Patients who have other pain, which could confound the assessment of the neuropathic pain due to PHN 4. Patients with polyneuropathy or other severe neurologic disease (e.g., multiple sclerosis) 5. Patients with diseases accompanied with a severe immunocompromised state (e.g., during chemotherapy, AIDS; HIV is not an exclusion criterion) 6. Use of coumarin anticoagulants 7. Contra-indications for spinal anaesthesia 8. Contra-indications for oral non-steroidal anti-inflammatory drug (NSAID) use 9. Satisfactory pain relief with conventional treatment (including at least one trycyclic antidepressant and at least one anti-epileptic) 10. Adjustments in concomitant PHN medication during the past 4 weeks 11. Previous spinal anaesthesia with steroids for PHN 12. Skin conditions in the area affected by the neuralgia that could alter sensation 13. Clinically significant psychiatric diagnoses, in particular depression, that would impair their reliable participation in this trial 14. Body Mass Index (BMI) >35 kg/m^2 15. Woman of childbearing potential who is not willing or unable to take adequate birth control measures during the study and for at least 6 months after the last injection 16. Pregnant patients and women who are lactating 17. Problems with communication (language, deafness, aphasia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global pain relief at 1-year follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Global pain relief at the end of treatment and after 4 weeks, 8 weeks, 6 months and 2 years follow-up 2. Reduction of VAS scores for global, burning and lancinating pain, and allodynia at the end of treatment and after 4 weeks, 8 weeks, 6 months, 1 year and 2 years follow-up 3. Reduction of areas of pain and allodynia at the end of treatment and after 4 weeks, 8 weeks, 6 months, 1 year and 2 years follow-up 4. Reduction in mean number of paracetamol tablets consumed per week at the end of treatment and after 4 weeks follow-up 5. Reduction in mean percentage of the maximal dose of NSAIDs used per week at the end of treatment and after 4 weeks follow-up 6. Reduction in the percentage of the initial dose(s) of PHN medication at the end of treatment and after 4 weeks follow-up 7. Euroqol EQ-5D scores just before treatment and at 4 weeks, 8 weeks, 6 months, 1 year and 2 year follow-up visits | — |
Countries
Netherlands
Outcome results
None listed