Erector Spinae Plane Block in Post-herpetic Neuralgia
Condition: Postherpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional

Summary: 
      This randomized clinical study will be carried out on 72 patients admitted to the pain clinic
      in Tanta University Hospitals with post-herpetic neuralgia.

      Cases presenting to the Pain Clinic with acute pain due to postherpetic neuralgia in thoracic
      and/or lumbar dermatomes with numerical rating scale (NRS) of 6 or more and they will be
      randomly divided, using the closed envelop method, into three equal groups.

      Group A (24 patients): Patients will be subjected to the routine medical treatment of post
      herpetic neuralgia as controls (Pregabalin, acyclovir, and paracetamol) and sham erector
      spinae plane block Group B (24 patients): Patients will be subjected to erector spinae block
      by bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose) together with medical
      treatment.

      Group C (24 patients): Patients that will subjected to erector spinae block by bupivacaine (2
      - 2.5 mg/kg, with a maximum of 175 mg/dose with the addition of MgSO4 (equivalent to 100 mg))
      together with medical treatment.

      Primary outcome will be the efficacy of pain relief Secondary outcome will be the frequency
      of pain and the consumption of analgesics.
    

Detailed description: 
      This comparative randomized controlled study will be conducted on 72 patients of both gender
      suffering from post-herpetic neuralgia and presented at Pain Clinics of Tanta University
      Hospitals for a period of 9 months (September 2020- June 2021) that will be started
      immediately after obtaining Ethical Committee approval. An informed written consent will be
      obtained from all the participants, all patients data will be confidential and will be used
      for the current study only.

      A total of 72 cases with post herpetic neuralgia will be included in the current study, and
      they will be randomly divided, using the closed envelop method, into three equal groups.

      Group A (24 patients): Patients will be subjected to the routine medical treatment of post
      herpetic neuralgia as controls (Pregabalin, acyclovir, and paracetamol) and sham erector
      spinae plane block Group B (24 patients): Patients will be subjected to erector spinae block
      by bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose) together with medical
      treatment.

      Group C (24 patients): Patients that will subjected to erector spinae block by bupivacaine (2
      - 2.5 mg/kg, with a maximum of 175 mg/dose with the addition of MgSO4 (equivalent to 100 mg))
      together with medical treatment.

        -  Management of the patients Before intervention, all cases will be subjected to complete
           history taking, physical examination, and routine laboratory and radiological
           investigations (if other causes rather than post herpetic neuralgia are suspected). Pre
           intervention pain will be evaluated by NRS and recorded for all cases.

        -  Measurements An assistant resident will help in obtaining and recording our
           measurements. All the patients will undergo regular follow up visits that will be
           arranged throughout the upcoming 3 months following injection as every week in the first
           month, then, every 2 weeks in the next two months.

             1. Demographic data: including age, gender, associated morbidities, and site of
                post-herpetic neuralgia.

             2. Duration of analgesia will be defined as the analgesia starting from the
                performance of the block until the first analgesic requirement or reporting a pain
                score of 4/10.(9)

             3. Frequency of pain

             4. Numerical rating score NRS (0- 10 metric score to assess the severity of pain where
                0= no pain and 10 = severe pain)

             5. Dose of pregabalin consumed per day to relief pain

             6. Dose of other analgesics required to control pain.
    

Intervention name(s): Medical treatment; Real Erector Spinae block; Real Erector Spinae block with magnesium sulphate; Sham Erector Spinae block
Intervention type(s): Drug; Procedure; Procedure; Procedure
Intervention description(s): routine medical treatment of post herpetic neuralgia as controls (Pregabalin, acyclovir, and paracetamol); Ultrasound guided Erector spinae plane block with injection of local anesthetic bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose); Ultrasound guided Erector spinae plane block with injection of local anesthetic bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose with the addition of MgSO4 (equivalent to 100 mg)); Ultrasound guided Erector spinae plane block with injection ofnormal saline
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Herpes Zoster; Postherpetic neuralgia; Erector spina plane block