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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04546334
Other study ID # 34043/08/20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 26, 2020
Est. completion date June 19, 2021

Study information

Verified date July 2021
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Medical treatment
routine medical treatment of post herpetic neuralgia as controls (Pregabalin, acyclovir, and paracetamol)
Procedure:
Real Erector Spinae block
Ultrasound guided Erector spinae plane block with injection of local anesthetic bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose)
Real Erector Spinae block with magnesium sulphate
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))
Sham Erector Spinae block
Ultrasound guided Erector spinae plane block with injection ofnormal saline

Locations

Country Name City State
Egypt Tanta University hospitals Tanta

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The efficacy of pain relief Numerical rating score NRS (0- 10 metric score to assess the severity of pain where 0= no pain and 10 = severe pain) within 3 months of theinjection
Secondary The frequency of pain The number of pain attacks (pain score of 4 or more) within 3 months of theinjection
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